Hymovis™ Versus Placebo in Knee Osteoarthritis

Fidia Pharma

Status and phase: Completed; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Procedure: Phosphate Buffered Saline Injection; Device: Hymovis Intra-articular Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01372475

R29-09-02

Details and patient eligibility

About

Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS] in subjects with symptomatic osteoarthritis of the knee.

Enrollment: 800 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
2. Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study

Exclusion criteria

1. Clinically significant apparent large effusion of the target knee;
2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
3. Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
4. Medical history of anaphylactic reactions
5. History of septic arthritis in any joint
6. Females who are pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups, including a placebo group

Hymovis Viscoelastic Hydrogel

Active Comparator group

Description:

Intra-articular Injection

Treatment:

Device: Hymovis Intra-articular Injection

Placebo

Placebo Comparator group

Description:

Phosphate Buffered Saline Intra-articular Injection

Treatment:

Procedure: Phosphate Buffered Saline Injection