A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00743587
First received: August 28, 2008
Last updated: March 10, 2010
Last verified: March 2010
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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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Pressure pain threshold - area under the curve [ Time Frame: 0 to 4 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pressure pain threshold - at specific time points [ Time Frame: 0 to 12 hours ] [ Designated as safety issue: No ]
- Present pain intensities - at specific time points [ Time Frame: 0 to 12 hours ] [ Designated as safety issue: No ]
| 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 |
Criteria
Inclusion Criteria:
- The clinical diagnosis of osteoarthritis of the hand, of at least 6 months duration.
- Pain around one of the thumb joints due to osteoarthritis. The patient must report the average pain in this joint, in the week prior to screening, as at least 5 on an 11-point numerical pain rating scale at the time of screening.
- The patient must demonstrate pressure pain at a thumb joint by reporting a pressure pain threshold lower than 300 kPa.
Exclusion Criteria:
- Pregnant (as judged by a urine pregnancy test) or lactating female.
- Other severe pain which may impair the assessment of the pain due to osteoarthritis.
- Skin condition over the thumb joint, which will be used for pain threshold testing, that could interfere with the assessment of pain thresholds.
- Known hypersensitivity to oxycodone, NSAIDS or tramadol.
- Patients in whom NSAIDS, oxycodone or tramadol are contraindicated, or patients taking any concurrent medications which are contraindicated with any of the study medications .
- An estimated renal clearance of less than 30 mL/min based on the Cockcroft Gault equation.
- Use of prohibited medications as listed below, in the absence of appropriate washout periods:
- Oral or intramuscular corticosteroids within 4 weeks prior to screening.
- Monoamine oxidase inhibitors within 2 weeks of screening.
- Analgesic agents, other than aspirin, or acetaminophen within 1 week prior to screening. (Aspirin use less than or equal to 325 mg per day for cardiovascular prophylaxis is permitted)
- Acetaminophen up to 4 g/day may be used, provided it is not used in the 24 hours prior to any assessment of pain thresholds.
- Intra-articular steroid injections into the study joint within 12 weeks, or to any other joint within 4 weeks, prior to screening.
- History of chronic constipation, or of any condition which, in the opinion of the investigator, may put the patient at increased risk of respiratory depression.
Contacts and Locations More Information
Additional Information:
No publications provided
| 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 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013