ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00279344
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Nycomed

Brief Summary:

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2004
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Primary:
  2. 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 :
  1. Secondary:
  2. 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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279344


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

ClinicalTrials.gov Identifier: NCT00279344     History of Changes
Other Study ID Numbers: FT-015-IN
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

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