An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee.
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|ClinicalTrials.gov Identifier: NCT00240799|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: acetaminophen extended release Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||542 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee.|
|Actual Study Completion Date :||October 2004|
acetaminophen extended release
|Drug: acetaminophen extended release|
Placebo Comparator: 002
- Average change from baseline through Week 12 for WOMAC pain subscale score. Average change from baseline through Week 12 for WOMAC physical function subscale score. Subject's average global assessment of response to therapy through Week 12.
- Average change from baseline through Week 12 for: WOMAC stiffness subscale score; total WOMAC Osteoarthritis Index; and Nottingham Health Profile Energy subscale score
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): NCT00240799
|Study Director:||McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial||McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.|