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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Thumbs
• Intervention / Treatment: Drug: Placebo; Drug: Oxycodone; Drug: Tramadol; Drug: Naproxen

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: Oxycodone; Oral, 1 x 20mg controlled-release tablets; Other Names: Oxycontin
Active Comparator: C	Drug: Tramadol; Oral, 2 x 50mg immediate release capsules; Other Names: Dolzam
Placebo Comparator: A	Drug: Placebo; Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
Active Comparator: D	Drug: Naproxen; Oral, 1 x 500mg enteric-coated; Other Names: Naprosyne

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pressure pain threshold - area under the curve	0 to 4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Pressure pain threshold - at specific time points	0 to 12 hours
Present pain intensities - at specific time points	0 to 12 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: August 28, 2008
• First Submitted That Met QC Criteria: August 28, 2008
• First Posted (Estimate): August 29, 2008

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Gout Suppressants; Tramadol; Oxycodone; Naproxen
• Other Study ID Numbers: A9001383