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HUPS: Hyalgan Use in Painful Shoulder

NCT00377624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2011-01-11

No results posted yet for this study

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

  • Osteoarthritis of Shoulder

Interventions

DRUG

sodium hyaluronate

Sponsors & Collaborators

Principal Investigators

  • Phyllis Diener, MT, ASCP · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Completion
2004-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00377624 on ClinicalTrials.gov