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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00345735
First received: June 26, 2006
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Pain
Drug: Fentanyl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Pain intensity difference at 10 minutes (PID10) after administration

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: May 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345735

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00345735     History of Changes
Other Study ID Numbers: FT-017-IM, 2005-002347-82
Study First Received: June 26, 2006
Last Updated: May 4, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
Finland: Finnish Medicines Agency
France: Ministry of Health
Italy: National Institute of Health
Poland: Ministry of Health

Keywords provided by Nycomed:
Cancer pain with breakthrough pain episodes

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014