A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb
NCT00743587
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Other | |||
Condition ICMJE | Osteoarthritis Thumbs | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 36 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2009 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00743587 | |||
Other Study ID Numbers ICMJE | A9001383 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |