CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 599 enrolled
Drug / intervention
Hyaluronate Injectable Viscosupplement +2 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/NCT02495857
NCT02495857N/ACompleted
CompareCT.gov

A Double-Blind, Randomized, Study of the Effectiveness and Safety of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee

Actavis Inc.·interventional·Posted Jul 13, 2015·Updated Jun 23, 2020

In Brief

A clinical study evaluating Hyaluronate Injectable Viscosupplement, Euflexxa IA injection, and 1 other intervention for Osteoarthritis. Completed, enrolled 599 participants across 2 sites.

Detailed Summary

The study is a prospective, multi-center, randomized, three-arm, parallel group, clinical study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of Investigational hyaluronate as compared to placebo injected into the target knee for the treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the investigational product will also be compared with Euflexxa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 13, 2015
Enrollment StartAug 15, 2015
Primary CompletionDec 5, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.0 years ago

Interventions

Hyaluronate Injectable Viscosupplementdevice

Test product of a 1% sodium hyaluronate for injection

Euflexxa IA injectiondevice

Brand product of a 1% sodium hyaluronate for injection

Placebodevice

0.9% sodium chloride, sterile