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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

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 points

Present 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

Page last updated: August 23, 2015

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