NCT00538850

Brief Summary

This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3 cancer

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 5, 2014

Completed
Last Updated

March 5, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

October 1, 2007

Results QC Date

May 8, 2013

Last Update Submit

January 14, 2014

Conditions

Cancer

Keywords

unspecified adult solid tumor, protocol specificpainadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)stage IV chronic lymphocytic leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemianoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent small lymphocytic lymphomarecurrent marginal zone lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromestage I multiple myelomastage II multiple myelomastage III multiple myelomade novo myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablepreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesatypical chronic myeloid leukemia, BCR-ABL1 negativestage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomacontiguous stage II adult Burkitt lymphomastage I adult Burkitt lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II small lymphocytic lymphomacontiguous stage II marginal zone lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage I small lymphocytic lymphomastage I marginal zone lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomacontiguous stage II mantle cell lymphomastage I mantle cell lymphomacontiguous stage II adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomastage I adult lymphoblastic lymphomarefractory multiple myelomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomarecurrent adult T-cell leukemia/lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromechronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiaessential thrombocythemiapolycythemia verarelapsing chronic myelogenous leukemiaT-cell large granular lymphocyte leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiasecondary acute myeloid leukemiaacute undifferentiated leukemiarefractory chronic lymphocytic leukemiastage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiarefractory hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemiarecurrent adult grade III lymphomatoid granulomatosisWaldenström macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomapost-transplant lymphoproliferative disorderextramedullary plasmacytomaisolated plasmacytoma of bonemonoclonal gammopathy of undetermined significanceprimary systemic amyloidosisadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult grade III lymphomatoid granulomatosisAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaintraocular lymphomameningeal chronic myelogenous leukemiaprimary central nervous system non-Hodgkin lymphomaprimary central nervous system Hodgkin lymphomastage I adult Hodgkin lymphomarecurrent squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage I adenoid cystic carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I verrucous carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III verrucous carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV verrucous carcinoma of the oral cavitystage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavitystage I basal cell carcinoma of the lipstage II basal cell carcinoma of the lipstage III basal cell carcinoma of the lipstage IV basal cell carcinoma of the lipmetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primaryrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage I lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityhigh-grade salivary gland mucoepidermoid carcinomalow-grade salivary gland mucoepidermoid carcinomarecurrent salivary gland cancersalivary gland acinic cell tumorsalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland anaplastic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland canceradult grade I meningiomaadult choroid plexus tumoradult craniopharyngiomaadult myxopapillary ependymomaadult diffuse astrocytomaadult pilocytic astrocytomaadult pineocytomaadult ependymomaadult subependymomaadult oligodendrogliomaadult subependymal giant cell astrocytomameningeal melanocytomaadult meningeal hemangiopericytomaadult pineal gland astrocytomaadult central nervous system germ cell tumoradult medulloblastomaadult supratentorial primitive neuroectodermal tumor (PNET)adult ependymoblastomaadult anaplastic astrocytomaadult anaplastic ependymomaadult glioblastomaadult gliosarcomaadult giant cell glioblastomaadult grade III meningiomaadult anaplastic oligodendrogliomaadult pineoblastomaadult mixed gliomarecurrent adult brain tumoradult anaplastic meningiomaadult papillary meningiomaadult brain stem gliomastage IA cervical cancerstage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage III cervical cancerstage IVA cervical cancerstage IVB cervical cancerrecurrent cervical cancerrecurrent endometrial carcinomastage I endometrial carcinomastage II endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomafallopian tube cancerrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage I ovarian epithelial cancerstage I ovarian germ cell tumorstage II ovarian epithelial cancerstage II ovarian germ cell tumorstage III ovarian epithelial cancerstage III ovarian germ cell tumorstage IV ovarian epithelial cancerstage IV ovarian germ cell tumorovarian sarcomaovarian stromal cancerrecurrent uterine sarcomastage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerrecurrent bladder cancerrecurrent gallbladder cancerstage I bladder cancerstage II bladder cancerstage III bladder cancerstage IV bladder cancerrecurrent gastric cancerstage I gastric cancerstage II gastric cancerstage III gastric cancerstage IV gastric canceradvanced adult primary liver cancerrecurrent small intestine cancerlocalized transitional cell cancer of the renal pelvis and uretermetastatic transitional cell cancer of the renal pelvis and ureterrecurrent renal cell cancerrecurrent transitional cell cancer of the renal pelvis and ureterregional transitional cell cancer of the renal pelvis and ureterstage I renal cell cancerstage II renal cell cancerstage III renal cell cancerstage IV renal cell cancerdistal urethral cancerproximal urethral cancerrecurrent urethral cancerurethral cancer associated with invasive bladder cancerstage I adrenocortical carcinomastage II adrenocortical carcinomastage III adrenocortical carcinomastage IV adrenocortical carcinomarecurrent adrenocortical carcinomaextragonadal germ cell tumorlocalized gastrointestinal carcinoid tumormetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumorgastrinomainsulinomaWDHA syndromeglucagonomapancreatic polypeptide tumorsomatostatinomarecurrent islet cell carcinomacarcinoma of the appendixlocalized extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerlocalized gallbladder cancerunresectable gallbladder cancergastrointestinal stromal tumorlocalized resectable adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent pancreatic cancersmall intestine adenocarcinomasmall intestine leiomyosarcomasmall intestine lymphomastage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancerpulmonary carcinoid tumorextensive stage small cell lung cancerlimited stage small cell lung cancerrecurrent small cell lung cancerliver metastaseslung metastasesprimary peritoneal cavity cancerlung papillomaperipheral primitive neuroectodermal tumor of the kidneyclear cell sarcoma of the kidneyrhabdoid tumor of the kidneycongenital mesoblastic nephromastage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancermale breast cancerbreast cancer in situlocalized osteosarcomametastatic osteosarcomarecurrent osteosarcomalocalized Ewing sarcoma/peripheral primitive neuroectodermal tumormetastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorchondrosarcomamalignant giant cell tumor of bonedesmoid tumorstage I adult soft tissue sarcomastage II adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomarecurrent adult soft tissue sarcomarecurrent thymoma and thymic carcinomaadvanced malignant mesotheliomalocalized malignant mesotheliomarecurrent malignant mesotheliomaphosphaturic mesenchymal tumorstage I malignant testicular germ cell tumorstage II malignant testicular germ cell tumorstage III malignant testicular germ cell tumorrecurrent malignant testicular germ cell tumorstage 0 penile cancerstage I penile cancerstage II penile cancerstage III penile cancerstage IV penile cancerrecurrent penile cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancerstage 0 vaginal cancerstage I vaginal cancerstage II vaginal cancerstage III vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerrecurrent vaginal cancerstage 0 vulvar cancerstage I vulvar cancerstage II vulvar cancerstage III vulvar cancerstage IVB vulvar cancerrecurrent vulvar cancerstage 0 anal cancerstage I anal cancerstage II anal cancerstage IIIA anal cancerstage IIIB anal cancerstage IV anal cancerrecurrent anal cancerstage 0 rectal cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent rectal cancerstage 0 esophageal cancerstage I esophageal cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal cancerstage I thymomastage II thymomastage III thymomastage IVA thymomastage IVB thymomarecurrent melanomastage 0 melanomastage IA melanomastage IB melanomastage IIA melanomastage IIB melanomastage IIC melanomastage IIIA melanomastage IIIB melanomastage IIIC melanomastage IV melanoma

Outcome Measures

Primary Outcomes (1)

  • Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)

    Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.

    Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode

Secondary Outcomes (3)

  • Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing

    Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode

  • Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing

    5 through 60 minutes after dosing for each pain episode

  • Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing

    30 through 60 minutes after dosing for each pain episode

Study Arms (1)

Fentanyl sublingual spray

EXPERIMENTAL

Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.

Drug: Fentanyl sublingual sprayDrug: Placebo

Interventions

Fentanyl sublingual sprayDRUG

In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. In the double-blind period of the study, participants received fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, or 1600 µg determined in the open-label titration period of the study.

Also known as: SUBSYS
Fentanyl sublingual spray
PlaceboDRUG

Matching placebo to fentanyl sublingual spray.

Fentanyl sublingual spray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, ≥ 18 years of age.
  • Diagnosis of cancer.
  • Opioid-tolerant. Subjects who were opioid tolerant were those taking ≥ 60 mg of oral morphine/day, at least 25 μg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer for cancer-related pain.
  • Experienced persistent pain related to the cancer or its treatment of moderate or lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the Screening Visit.
  • Over the previous 7 days, subject experienced, on average, 1 to 4 breakthrough cancer pain episodes per day usually at least partially controlled by supplemental medication of at least 5 mg immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone, hydrocodone, or codeine with acetaminophen).
  • Able to evaluate and record pain relief, assess medication performance at set times after dosing, record AEs, record each use of the study drug or supplemental medication in an electronic diary (a caregiver may have provided the subject the medication, help with the mechanics of handling the electronic diary but was not permitted to record any information in the electronic diary).
  • Able and willing to give informed consent.
  • Women of childbearing potential were to have a) a negative serum pregnancy test, b) not be breastfeeding and c) agree to practice a reliable form of contraception.

You may not qualify if:

  • Intolerance to opioids or fentanyl.
  • Current use of commercially available oral short-acting fentanyl for breakthrough pain. Subjects previously on Actiq or Fentora were permitted to be enrolled if they had a 7 day washout.
  • Rapidly increasing/uncontrolled pain.
  • A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids.
  • Uncontrolled hypertension (systolic blood pressure {SBP} \> 180 mmHg or diastolic blood pressure \[DBP\] \> 90 mmHg on 2 occasions ≥ 6 hours apart) despite antihypertensive therapy, or a history of hypertensive crisis within the past 2 years.
  • A recent history (≤ 2 years prior) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
  • Clinically uncontrolled sleep apnea.
  • Brain metastases with signs or symptoms of increased intracranial pressure.
  • Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy.
  • Received investigational study product(s) ≤ 30 days prior to the Screening Visit.
  • Painful erythema, oedema or ulcers under the tongue.
  • Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InSys Therapeutics, Incorporated

Chandler, Arizona, 85224, United States

Location

Related Publications (2)

  • Rauck R, Reynolds L, Geach J, Bull J, Stearns L, Scherlis M, Parikh N, Dillaha L. Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2012 May;28(5):859-70. doi: 10.1185/03007995.2012.683111. Epub 2012 May 2.

    PMID: 22480131RESULT

  • Alberts DS, Smith CC, Parikh N, Rauck RL. Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl. Pain Manag. 2016 Oct;6(5):427-34. doi: 10.2217/pmt-2015-0009. Epub 2016 Mar 29.

    PMID: 27020837DERIVED

MeSH Terms

Conditions

NeoplasmsPainCongenital AbnormalitiesLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularLymphoma, Mantle-CellHodgkin DiseaseLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeMultiple MyelomaMyeloproliferative DisordersLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyPrecursor T-Cell Lymphoblastic Leukemia-LymphomaPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicThrombocythemia, EssentialPolycythemia VeraLeukemia, Large Granular LymphocyticLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, AcuteLeukemia, Hairy CellLeukemia, ProlymphocyticWaldenstrom MacroglobulinemiaMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain AmyloidosisIntraocular LymphomaSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland NeoplasmsChoroid Plexus NeoplasmsCraniopharyngiomaEpendymomaAstrocytomaPinealomaGlioma, SubependymalOligodendrogliomaMedulloblastomaNeuroectodermal Tumors, PrimitiveGlioblastomaGliosarcomaMeningiomaGliomaBrain NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsCarcinoma, Ovarian EpithelialColonic NeoplasmsUrinary Bladder NeoplasmsGallbladder NeoplasmsStomach NeoplasmsCarcinoma, Renal CellUrethral NeoplasmsAdrenocortical CarcinomaGastrinomaInsulinomaVipomaGlucagonomaSomatostatinomaCarcinoma, Islet CellAppendiceal NeoplasmsBile Duct NeoplasmsGastrointestinal Stromal TumorsCarcinoma, HepatocellularPancreatic NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaNephroma, MesoblasticBreast NeoplasmsBreast Neoplasms, MaleBreast Carcinoma In SituOsteosarcomaNeuroectodermal Tumors, Primitive, PeripheralChondrosarcomaDesmoid TumorsSarcomaThymomaMesothelioma, MalignantTesticular NeoplasmsPenile NeoplasmsProstatic NeoplasmsVaginal NeoplasmsVulvar NeoplasmsAnus NeoplasmsRectal NeoplasmsEsophageal NeoplasmsMelanoma

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidBone Marrow DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyelodysplastic-Myeloproliferative DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphomaLymphoma, T-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphadenopathyBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteLeukemia, T-CellHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesEye NeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialHead and Neck NeoplasmsNeuroblastomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCerebral Ventricle NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNeoplasms, Vascular TissueMeningeal NeoplasmsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesAdenocarcinomaKidney NeoplasmsKidney DiseasesUrethral DiseasesAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesPancreatic DiseasesAdenoma, Islet CellAdenomaCarcinoma, NeuroendocrineNeuroendocrine TumorsCecal NeoplasmsCecal DiseasesBile Duct DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueLiver NeoplasmsLiver DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Complex and MixedBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituNeoplasms, Bone TissueFibromaNeoplasms, Fibrous TissueThymus NeoplasmsMesotheliomaNeoplasms, MesothelialPleural NeoplasmsGenital Neoplasms, MaleGenital Diseases, MaleTesticular DiseasesPenile DiseasesProstatic DiseasesVaginal DiseasesVulvar DiseasesAnus DiseasesRectal DiseasesEsophageal DiseasesNevi and MelanomasSkin Neoplasms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Larry Dillaha, M.D., Chief Medical Officer
Organization
Insys Therapeutics, Inc.
ldillaha@insysrx.com
602 910-2617

Study Officials

  • Larry Dillaha, MD

    INSYS Therapeutics Inc

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 3, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2010

Study Completion

October 1, 2010

Last Updated

March 5, 2014

Results First Posted

March 5, 2014

Record last verified: 2014-01

Locations

US(1)