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. 2006 Apr 19;2006(2):CD005321. doi: 10.1002/14651858.CD005321.pub2

NCT00130468.

Trial name or title A double blind, randomized trial of intra‐articular injections of 20 mg of Hyalgan for the treatment of knee pain due to osteoarthritis (three injection‐regimen for efficacy and duration ‐ 20 mg/2ml dose: Tread‐20)
Methods  
Participants Phase IV randomised, double‐blind, placebo controlled, parallel group
 Inclusion criteria:
 12 criteria:
 written consent,
 40 yr of age and above,
 of sufficient good health to be able to complet 6‐month follow‐up,
 signs and symptoms of OA of at least one knee according to ACR criteria,
 Kellgren‐Lawrence Grade II or III,
 symptoms including knee joint pain, crepitus, swelling, and/or effusion of the knee for at least 6 mths,
 pts on analgesic/NSAID VAS pain score after walking on a 50 foot flat surface of greater than or equal to 30 mm but less than 90 mm,
 if not taking analgesic/NSAIDVAS pain score after walking of greater than 40 mm but less than 90 mm,
 if bilateral knee pain is present, investigator will select the more painful knee
 Exclusion criteria:
 4 general,
 28 musculoskeletal related,
 16 concomitant conditions, diseases, medications and/or clinical history related
Interventions Hyalgan
Outcomes  
Starting date  
Contact information Suzanne Meeves
 Study Director
 Sanofi‐Aventis
Notes Sponsored by Sanofi‐Aventis
 ClinicalTrials.gov Identifier:
 NCT00130468