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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 Thumbs |
Drug: Placebo Drug: Oxycodone Drug: Tramadol Drug: Naproxen |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| 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 |
|---|---|
| Placebo Comparator: A |
Drug: Placebo
Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
|
| Active Comparator: B |
Drug: Oxycodone
Oral, 1 x 20mg controlled-release tablets
Other Name: Oxycontin
|
| Active Comparator: C |
Drug: Tramadol
Oral, 2 x 50mg immediate release capsules
Other Name: Dolzam
|
| Active Comparator: D |
Drug: Naproxen
Oral, 1 x 500mg enteric-coated
Other Name: Naprosyne
|
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: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00743587 History of Changes |
| Other Study ID Numbers: | A9001383 |
| Study First Received: | August 28, 2008 |
| Last Updated: | March 10, 2010 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Naproxen Oxycodone Tramadol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Narcotics Central Nervous System Depressants Analgesics, Opioid |