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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
This study has been completed.
First Received: August 28, 2008   Last Updated: April 13, 2009   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00743587
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Placebo
Drug: Oxycodone
Drug: Tramadol
Drug: Naproxen
Phase I

Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pressure pain threshold - area under the curve [ Time Frame: 0 to 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pressure pain threshold - at specific time points [ Time Frame: 0 to 12 hours ] [ Designated as safety issue: No ]
  • Present pain intensities - at specific time points [ Time Frame: 0 to 12 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Placebo Comparator Drug: Placebo
Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
B: Active Comparator Drug: Oxycodone
Oral, 1 x 20mg controlled-release tablets
C: Active Comparator Drug: Tramadol
Oral, 2 x 50mg immediate release capsules
D: Active Comparator Drug: Naproxen
Oral, 1 x 500mg enteric-coated

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743587

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A9001383
Study First Received: August 28, 2008
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00743587     History of Changes
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Oxycodone
Physiological Effects of Drugs
Gout Suppressants
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Analgesics, Opioid
Naproxen
Tramadol
Joint Diseases
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Rheumatic Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010