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

Condition(s) targeted: Osteoarthritis

Intervention: Placebo (Drug); Oxycodone (Drug); Tramadol (Drug); Naproxen (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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: Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study

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

Detailed description: Methodology study to evaluate whether the thumb OA model can detect the analgesic activity of agents with differing mechanisms of action.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Bruxelles 1070, Belgium; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: September 2008
Ending date: March 2009
Last updated: February 2, 2009