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Trial record 1 of 1 for:    NCT00743587
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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

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.
 
ClinicalTrials.gov Identifier: NCT00743587
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : December 4, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 28, 2008
First Posted Date  ICMJE August 29, 2008
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE September 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
Pressure pain threshold - area under the curve [ Time Frame: 0 to 4 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Osteoarthritis Thumbs
Intervention  ICMJE
  • Drug: Placebo
    Oral, a double-dummy approach will be used to maintain the blind between active tablet and capsule doses
  • Drug: Oxycodone
    Oral, 1 x 20mg controlled-release tablets
    Other Name: Oxycontin
  • Drug: Tramadol
    Oral, 2 x 50mg immediate release capsules
    Other Name: Dolzam
  • Drug: Naproxen
    Oral, 1 x 500mg enteric-coated
    Other Name: Naprosyne
Study Arms  ICMJE
  • Placebo Comparator: A
    Intervention: Drug: Placebo
  • Active Comparator: B
    Intervention: Drug: Oxycodone
  • Active Comparator: C
    Intervention: Drug: Tramadol
  • Active Comparator: D
    Intervention: Drug: Naproxen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2008)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00743587
Other Study ID Numbers  ICMJE A9001383
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP