A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis Thumbs
Intervention: Placebo (Drug); Oxycodone (Drug); Tramadol (Drug); Naproxen (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Pressure pain threshold - area under the curve
Secondary outcome: Pressure pain threshold - at specific time pointsPresent pain intensities - at specific time points
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Bruxelles 1070, Belgium
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2008
Last updated: March 10, 2010
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