Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00279344
First received: December 14, 2005
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

Primary objectives:

  • To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment
  • To assess the safety of FITpatch compared to standard opioid treatment

Secondary objectives:

  • To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment
  • To assess Quality of life reported with FITpatch compared to standard opioid treatment

Condition Intervention Phase
Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.
Drug: Fentanyl (Matrifen)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Primary:
  • To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment

Secondary Outcome Measures:
  • Secondary:
  • To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment

Estimated Enrollment: 220
Study Start Date: September 2004
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50.

  1. Subject informed consent given.
  2. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
  3. No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
  4. No impaired respiratory function nor neurological or psychiatric impairment.
  5. No known abuse of drug, narcotic or alcohol.
  6. Not pregnant or nursing.
  7. Not hypersensitive/allergic to fentanyl or morphine.
  8. No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness.
  9. Not participating in other clinical trials.

Exclusion Criteria:

All exclusion criteria must be answered No for a patient to participate in the trial.

  1. Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches?
  2. Does the patient have a known abuse of drug, narcotic or alcohol?
  3. Is the patient pregnant or nursing?
  4. Has the patient neurological or mental impairment that may compromise data collection?
  5. Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication?
  6. Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness?
  7. Does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?
  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: NCT00279344

Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Project Management Headquaters
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279344     History of Changes
Other Study ID Numbers: FT-015-IN
Study First Received: December 14, 2005
Last Updated: May 4, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Sweden: Medical Products Agency
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Chronic 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 14, 2014