CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
SUPARTZ® +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00479687
NCT00479687N/ACompleted
CompareCT.gov

A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain

Bioventus LLC·interventional·Posted May 28, 2007·Updated Apr 27, 2021

In Brief

A clinical study evaluating SUPARTZ® and Phosphate Buffered Saline for Osteoarthritis of the Shoulder. Completed, enrolled 300 participants.

Detailed Summary

This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with phosphate buffered saline (PBS) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. Phase I is 26 weeks, double blinded, and subjects are randomized to either SUPARTZ or PBS treatment. Phase II is 26 weeks (total 52 weeks) and open-label so all subjects will receive SUPARTZ injections only.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Shoulder
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 28, 2007
Enrollment StartMay 1, 2007
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 19.1 years ago

Interventions

SUPARTZ®device

Three Supartz injections over 2 weeks into the glenohumeral joint space.

Phosphate Buffered Salinedevice

Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.