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

May 4, 2012 updated by: Nycomed

Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients. A Randomised, Double-blind, Placebo-controlled, Cross-over Confirmatory Trial Testing Fentanyl and Placebo in Eight Breakthrough Pain Episodes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Is the patient a cancer patient with breakthrough pain?
  3. Is the patient aged ≥ 18 years?
  4. Has the patient received, for at least the past month, either oral morphine, oxycodone, hydromorphone, or transdermal fentanyl for treatment of background pain?
  5. 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?
  6. 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?
  7. 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?
  8. 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?
  9. 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?
  10. Is the life expectancy of the patient at least 3 months?
  11. Is the patient able to use intranasal drugs?
  12. Does the patient use adequate contraceptive precautions (contraceptive pill, implant or injection, or intrauterine device) in the trial period?
  13. Does the patient have a negative pregnancy test?
  14. 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?
  15. Did the patient have at least three BTP episodes during the seven days but no more than four BTP episodes per day?
  16. Was the BTP(s) of such severe pain intensity that the patient took additional analgesics (apart from the usual background pain opioid)?

Exclusion Criteria:

  1. Does the patient have a recent history of substance abuse?
  2. Is the patient pregnant or nursing during the trial period?
  3. Does the patient have neurological or psychiatric impairment that may compromise data collection?
  4. Does the patient have severe hepatic impairment? (Investigator's judgement according to local practice.)

  5. 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?
  6. Has the patient had facial radiotherapy?
  7. Has the patient been treated with a monoamine oxidase (MAO) inhibitor within the last 14 days?
  8. Does the patient use methadone or buprenorphine?
  9. 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?
  10. Does the patient use drugs for intranasal administration?
  11. Does the patient have a nasopharyngeal probe?
  12. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?
  13. 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?
  14. Is the patient concomitantly participating in any other trial with an investigational drug or device apart from cancer treatment and participation in NAF trial FT-016-IM within 30 days prior to inclusion in this trial?
  15. Does the patient have pathological conditions of the nasal cavity as contraindications to intranasal fentanyl?

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain intensity difference at 10 minutes (PID10) after administration

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nycomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT-017-IM
  • 2005-002347-82

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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