Fentanyl for Breakthrough Pain in the Emergency Department

NCT01812759 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 2012-0982NCI-2014-00915
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department. In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect. You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.

Conditions

Pain

Keywords

Pain; Breakthrough cancer pain; Emergency Department; ED; Fentanyl nasal spray; Lazanda; Placebo nasal spray; Hydromorphone PCA; Dilaudid

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.

  Primary outcome is total pain relief score (TOTPAR4) at 4 hours after treatment initiation. TOTPAR4 defined as the sum of hourly pain relief scores after baseline to four hours after the first administered dose of Lazanda or placebo. Scores range from -1 (worse pain) to 4 (complete relief). Range of possible TOTPAR4 summed scores is -4 to 16. A TOTPAR4 score greater than or equal to 8 is considered a positive response.

  4 hours

Study Arms (2)

Fentanyl Nasal Spray + Hydromorphone PCA

EXPERIMENTAL

Fentanyl 100 mcg nasal spray administered plus hydromorphone PCA. All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

Drug: Fentanyl Nasal Spray; Drug: Hydromorphone PCA

Placebo Nasal Spray + Hydromorphone PCA

EXPERIMENTAL

Placebo nasal spray administered plus hydromorphone PCA . All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

Drug: Hydromorphone PCA; Other: Placebo Nasal Spray

Interventions

Fentanyl Nasal Spray DRUG

100 mcg nasal spray administered in each nostril.

Also known as: Lazanda

Fentanyl Nasal Spray + Hydromorphone PCA

Hydromorphone PCA DRUG

Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

Also known as: Dilaudid

Fentanyl Nasal Spray + Hydromorphone PCA; Placebo Nasal Spray + Hydromorphone PCA

Placebo Nasal Spray OTHER

1 placebo nasal spray administered in each nostril.

Placebo Nasal Spray + Hydromorphone PCA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients presenting to the Emergency Department for treatment of acute breakthrough pain who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.)
• Patients must have severe pain on an 11-point Numeric Rating Scale (NRS 7-10)
• Breakthrough cancer pain must be of sufficient severity to warrant the use of intravenous opioids in the judgment of the treating emergency physician
• Age between 18 and 75 years
• Able to understand the description of the study and give informed consent
• Patients must be willing to and capable of providing frequent pain assessments for up to 8 hours
• English-speaking

You may not qualify if:

• Patients will not be approached while they are in acute distress and those exhibiting symptoms (such as dyspnea, uncontrolled nausea/vomiting or vertigo) to such an extent that impairs their ability to understand and evaluate informed consent
• Patients participating in other clinical trials for pain
• Patients who are not already tolerant to opioids
• Patients, who in the judgment of the treating clinician, are suspected to have hepatic or renal failure
• Patients who are pregnant or lactating
• Patients with a known allergy or significant reaction to fentanyl, the components of the IN formulation, hydromorphone, or other opioids
• Patients already on high morphine equivalent daily dose (MEDDs) (\>500 mg/day).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Archimedes Pharma US, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Pain; Emergencies

Interventions

Fentanyl; Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Kumar Alagappan,Chair, Emergency Medicine
• Organization: UT MD Anderson Cancer Center

kalagappan@mdanderson.org

(713) 745-9911

Study Officials

• Knox H. Todd, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: January 10, 2014
• Primary Completion: October 22, 2014
• Study Completion: October 22, 2014
• Last Updated: June 29, 2021
• Results First Posted: October 14, 2020

Record last verified: 2021-06

Locations

US (1)