A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis
|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: NCT00411164|
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : July 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip Osteoarthritis, Knee||Drug: OROS hydromorphone HCI (slow release)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||990 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 3, Randomized, Double-Blind, Fixed-Dose, Parallel Group Comparison of Controlled-Release Hydromorphone HCI vs Placebo in Subjects With Osteoarthritis|
|Study Start Date :||November 2003|
|Actual Study Completion Date :||May 2005|
- Time-interval weighted AUC pain ratio (AUC/by an individual's maximum possible benefit AUC)using Baseline Observation Carried Forward imputation(up to Week 12); AUC was the cumulative pain intensity differences from baseline (titration and maintenance).
- WOMAC pain subscale for the AUC ratio and change from baseline at each time point; Index score and other subscale analyzed using the AUC ratio and change from baseline (no imputation, BOCF and LOCF imputation); Other included MOS Sleep Scale.
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): NCT00411164
|Study Director:||Alza Corporation Clinical Trial||ALZA|