Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase IIb, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of MM-II in subjects with symptomatic knee OA as compared to matching placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharmaceutical Industries Limited
• Collaborator: Moebius Medical Ltd.

Criteria

Inclusion Criteria:

1. Subject is able to provide written consent, understand study requirements, is prepared to complete study procedures and is able to independently communicate meaningfully with study personnel

2. Presence of index knee pain for at least 6 months prior to Screening

3. Men or women ≥ 40 years of age at the time of Screening

4. Radiographic evidence of knee Osteoarthritis

Exclusion Criteria:

1. Pain in the contralateral knee with a severity of ≥ 30 mm on a 100 mm VAS

2. Presence of ≥ 40 mm on a 100 mm VAS pain in any other joints

3. Concomitant moderate or large size synovial fluid effusion of the index knee at Screening .

4. Known diagnosis of infection in the index knee in the past five years prior to Screening