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. 2019 May 27;2019(5):CD005522. doi: 10.1002/14651858.CD005522.pub3

NCT00832416.

Methods Study title: a four‐arm study comparing the analgesic efficacy and safety of tramadol once a day 100, 200 and 300 mg versus placebo for the treatment of pain due to osteoarthritis of the knee.
Methods not provided.
Participants Diagnosed with moderate to severe OA of the knee, consistent with the ACR clinical classification criteria for arthritis of the knee, and aged 40–75 years
Interventions Tramadol 100 mg daily
Tramadol 200 mg daily
Tramadol 300 mg daily
Placebo
Outcomes Major outcomes
  1. Patient global rating of pain for the study period (12 weeks)

  2. Percentage difference between WOMAC Pain subscale score from baseline to end of study (week 12)

  3. Percentage difference between WOMAC Physical Function subscale score from baseline to end of study (week 12)


Minor outcomes
  1. Percentage difference in WOMAC Pain subscale score from baseline to intervening visits (visits 2–4)

  2. Percentage difference in WOMAC Physical Function subscale score from baseline to intervening visits (visits 2–4)

  3. Multiple dose effect using 24‐hour VAS Pain Questionnaire

  4. Investigator global rating of pain relief

  5. Percentage of participants who dropped out from trial by dropout reason

Notes Study start date: January 2003
Primary completion date: August 2003
Contact information:
Address: 480 boulevard, Armand‐Frappier, Laval, Québec, H7V 4B4
Email: info@labopharm.com
Phone: 450 680‐2444
ClinicalTrials.gov identifier: NCT00832416