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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743587
First Posted: August 29, 2008
Last Update Posted: March 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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 Thumbs Drug: Placebo Drug: Oxycodone Drug: Tramadol Drug: Naproxen Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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 ]

Secondary Outcome Measures:
  • Pressure pain threshold - at specific time points [ Time Frame: 0 to 12 hours ]
  • Present pain intensities - at specific time points [ Time Frame: 0 to 12 hours ]

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
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: B Drug: Oxycodone
Oral, 1 x 20mg controlled-release tablets
Other Name: Oxycontin
Active Comparator: C Drug: Tramadol
Oral, 2 x 50mg immediate release capsules
Other Name: Dolzam
Active Comparator: D Drug: Naproxen
Oral, 1 x 500mg enteric-coated
Other Name: Naprosyne

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00743587     History of Changes
Other Study ID Numbers: A9001383
First Submitted: August 28, 2008
First Posted: August 29, 2008
Last Update Posted: March 11, 2010
Last Verified: March 2010

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