Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments hymovis, placebo
Sponsor Fidia Farmaceutici s.p.a.
Start date June 2014
End date February 2016
Trial size 332 participants
Trial identifier NCT02187549, EQE7-13-01

Summary

The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
HYADD(TM) 4 Hydrogel Intra-Articular Injection
hymovis HYADD(TM) 4 Hydrogel Intra-Articular Injection
Intra-articular injection
(Placebo Comparator)
Saline Intra-Articular Injection
placebo Placebo Intra-Articular Injection
Intra-Articular Injection

Primary Outcomes

Measure
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
time frame: 26 weeks

Secondary Outcomes

Measure
Patient Global Assessment
time frame: 26 weeks

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - Symptomatic osteoarthritis of the knee. Exclusion Criteria: - No disorders which could interfere with study required assessments.

Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Fidia Farmaceutici s.p.a..