Status:
COMPLETED
Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)
Lead Sponsor:
Nycomed
Conditions:
Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
- Subject informed consent given.
- Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
- No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
- No impaired respiratory function nor neurological or psychiatric impairment.
- No known abuse of drug, narcotic or alcohol.
- Not pregnant or nursing.
- Not hypersensitive/allergic to fentanyl or morphine.
- No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness.
- Not participating in other clinical trials.
Exclusion
- All exclusion criteria must be answered No for a patient to participate in the trial.
- 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?
- Does the patient have a known abuse of drug, narcotic or alcohol?
- Is the patient pregnant or nursing?
- Has the patient neurological or mental impairment that may compromise data collection?
- Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication?
- Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness?
- 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?
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00279344
Start Date
September 1 2004
End Date
August 1 2007
Last Update
May 7 2012
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