Trials / Completed
CompletedNCT00377624
HUPS: Hyalgan Use in Painful Shoulder
Sodium Hyaluronate for Treatment of Chronic Painful Shoulder With Limitation of Motion Due to Glenohumeral Joint Osteoarthritis, Rotator Cuff Tear and/or Primary or Secondary Adhesive Capsulitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 602 (planned)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 35 Years
- Healthy volunteers
- Not accepted
Summary
Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical trial. In order to avoid problems in the interpretation of the final results due to disparate enrollment from various centers, the number of patients enrolled per site will be the same per site. Study patients will be randomized to receive either 20 mg sodium hyaluronate, 3 i.a. sodium hyaluronate injections, followed by 2 PBSaline mock i.a. injections or 5 i.a. PB-Saline control injections. One investigator will administer the injection and the joint assessor will be blinded to the study. The anterior or posterior approach for the shoulder injection will be used.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sodium hyaluronate |
Timeline
- Start date
- 2002-01-01
- Completion
- 2004-09-01
- First posted
- 2006-09-18
- Last updated
- 2011-01-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00377624. Inclusion in this directory is not an endorsement.