ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

This study has been completed.

Sponsored by: Nycomed
Information provided by: Nycomed
ClinicalTrials.gov Identifier: NCT00279344
  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 III

MedlinePlus related topics:   Cancer   

Drug Information available for:   Fentanyl Citrate    Fentanyl   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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.

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

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


Study ID Numbers:   FT-015-IN
First Received:   December 14, 2005
Last Updated:   February 26, 2008
ClinicalTrials.gov Identifier:   NCT00279344
Health Authority:   Austria: Federal Ministry for Health and Women;   Denmark: Danish Medicines Agency;   Finland: National Agency for Medicines;   Norway: Norwegian Medicines Agency;   Russia: Pharmacological Committee, Ministry of Health;   Sweden: Medical Products Agency;   Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:
Fentanyl
Pain

Additional relevant MeSH terms:
Anesthetics, Intravenous
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on October 24, 2008




Links to all studies - primarily for crawlers