Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients (FT-017-IM)

NCT00345735 | Completed Phase 2

• 2 other identifiers: FT-017-IM2005-002347-82
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain (BTP) in cancer patients. Secondary Objective: To explore the relationship between the response to the fentanyl dose and the stable background pain opioid dose.

Conditions

Cancer; Pain

Keywords

Cancer pain with breakthrough pain episodes

Outcome Measures

Primary Outcomes (1)

• Pain intensity difference at 10 minutes (PID10) after administration

Secondary Outcomes (1)

• Sum of pain intensity differences over the 0-60 minute time interval (SPID0-60) and General Impression (GI) with 5 point verbal rating scale at 60 minutes

Interventions

Fentanyl DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has the patient given informed consent according to local requirements before any trial-related activities? Trial-related activities are any procedures that would not have been performed during the routine management of the patient.
• Is the patient a cancer patient with breakthrough pain?
• Is the patient aged ≥ 18 years?
• Has the patient received, for at least the past month, either oral morphine, oxycodone, hydromorphone, or transdermal fentanyl for treatment of background pain?
• Is the current dose of the scheduled background pain opioid of the patient equivalent to 60-500 mg oral morphine/day or to 25-200 µg/hour transdermal fentanyl?
• Is the background pain generally stable and on average controlled to a mild level (defined as ≤ 4 on an 11-point numerical rating scale \[NRS\]) by the background pain opioid?
• Is the BTP(s) in general of such severe pain intensity that the patient judges he/she needs additional analgesics (apart from background pain medication) and does it normally last for more than 15 minutes?
• Does the patient, in general, while using a stable fixed-schedule opioid regimen have at least three BTP episodes per week but no more than four BTP episodes per day?
• Has the patient obtained at least partial relief of BTP(s) with his/her usual immediate-release strong opioid, i.e. oral morphine, oxycodone, hydromorphone or transmucosal fentanyl?
• Is the life expectancy of the patient at least 3 months?
• Is the patient able to use intranasal drugs?
• Does the patient use adequate contraceptive precautions (contraceptive pill, implant or injection, or intrauterine device) in the trial period?
• Does the patient have a negative pregnancy test?
• Was the background pain, during a minimum of five of the seven days, controlled to a mild level (defined as ≤ 4 on an 11-point NRS) by the background pain opioid?
• Did the patient have at least three BTP episodes during the seven days but no more than four BTP episodes per day?

You may not qualify if:

• Does the patient have a recent history of substance abuse?
• Is the patient pregnant or nursing during the trial period?
• Does the patient have neurological or psychiatric impairment that may compromise data collection?
• Does the patient have severe hepatic impairment? (Investigator's judgement according to local practice.)
• Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background pain opioid will be:
• less than 60 mg morphine or morphine equivalents/day; or
• less than 25 µg/hour transdermal fentanyl or the number of BTP episodes will be less than three per week during the trial period?
• Has the patient had facial radiotherapy?
• Has the patient been treated with a monoamine oxidase (MAO) inhibitor within the last 14 days?
• Does the patient use methadone or buprenorphine?
• Does the patient have impaired respiratory function to an extent which may severely increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment?
• Does the patient use drugs for intranasal administration?
• Does the patient have a nasopharyngeal probe?
• Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?
• Does the patient have any head injury, primary brain tumour, or other pathological conditions which could significantly increase the risk of increased intracranial pressure or impaired consciousness?

Sponsors & Collaborators

• Nycomed: lead

Study Sites (1)

Nycomed

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nycomed Clinical Trial Operations

  Headquarters

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 26, 2006
• First Posted: June 28, 2006
• Study Start: May 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

DK (1)