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Sponsored by: |
Nycomed |
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Information provided by: | Nycomed |
ClinicalTrials.gov Identifier: | NCT00279344 |
Primary objectives:
Secondary objectives:
Condition | Intervention | Phase |
---|---|---|
Standard Opioid Analgesic Treatment of Cancer-Related Chronic Pain. |
Drug: Fentanyl (Matrifen) |
Phase III |
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. |
Estimated Enrollment: | 220 |
Study Start Date: | September 2004 |
Study Completion Date: | August 2007 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Exclusion Criteria:
All exclusion criteria must be answered No for a patient to participate in the trial.
Study ID Numbers: | FT-015-IN |
Study 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 |
Fentanyl Pain |
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 |