HUPS: Hyalgan Use in Painful Shoulder

Osteoarthritis of Shoulder Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Shoulder

• NCT number: NCT00377624
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: January 2002
• Completion date: September 2004