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A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis Thumbs
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00743587
Pfizer
Completed
A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

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Pfizer Clinical Trials Contact Center

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[email protected]

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