drugset / Trial / NCT00377624

HUPS: Hyalgan Use in Painful Shoulder

NCT00377624

Phase 3 Completed 602 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2002-01
Primary completion
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Hyaluronate Other / unclassified 20 mg Other

Indications