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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00743587 |
Purpose
The purpose of this study is to determine if the measurement of pressure pain thresholds, in patients suffering osteoarthritis of the thumb, can be used to assess the activity of potential analgesic agents after a single dose. The study will use agents known to give pain relief in osteoarthritis as positive controls. These agents are: tramadol, naproxen and oxycodone.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Placebo Drug: Oxycodone Drug: Tramadol Drug: Naproxen |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo And Active Controlled Methodology Study Investigating The Effects Of Tramadol And Naproxen On The Pain Thresholds Of Patients With Severe Pain Due To Osteoarthritis Of The Thumb |
| Enrollment: | 36 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Placebo Comparator |
Drug: Placebo
Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
|
| B: Active Comparator |
Drug: Oxycodone
Oral, 1 x 20mg controlled-release tablets
|
| C: Active Comparator |
Drug: Tramadol
Oral, 2 x 50mg immediate release capsules
|
| D: Active Comparator |
Drug: Naproxen
Oral, 1 x 500mg enteric-coated
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A9001383 |
| Study First Received: | August 28, 2008 |
| Last Updated: | April 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00743587 History of Changes |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Osteoarthritis Oxycodone Physiological Effects of Drugs Gout Suppressants Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Analgesics, Opioid |
Naproxen Tramadol Joint Diseases Cyclooxygenase Inhibitors Central Nervous System Depressants Enzyme Inhibitors Narcotics Rheumatic Diseases Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |