Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)
NCT00279344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2012-05-07
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
Conditions
- Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.
Interventions
- DRUG
-
Fentanyl (Matrifen)
Sponsors & Collaborators
-
Nycomed
lead INDUSTRY
Principal Investigators
-
Nycomed Clinical Project Management · Headquaters
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Completion
- 2007-08-31
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