Status:
COMPLETED
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Collaborating Sponsors:
Moebius Medical Ltd.
Nordic Bioscience Clinical Development (NBCD)
Conditions:
Osteoarthritis of Knee
Eligibility:
All Genders
40-99 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Presence of index knee pain for at least 6 months prior to Screening
- Men or women ≥ 40 years of age at the time of Screening
- Radiographic evidence of knee Osteoarthritis
Exclusion
- Pain in the contralateral knee with a severity of ≥ 30 mm on a 100 mm VAS
- Presence of ≥ 40 mm on a 100 mm VAS pain in any other joints
- Concomitant moderate or large size synovial fluid effusion of the index knee at Screening .
- Known diagnosis of infection in the index knee in the past five years prior to Screening
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2022
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT04506463
Start Date
December 22 2020
End Date
August 10 2022
Last Update
August 29 2024
Active Locations (25)
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1
Sunpharma site no. 20
Birmingham, Alabama, United States, 35209
2
Sunpharma site no. 11
Tempe, Arizona, United States, 85283
3
Sunpharma site no. 25
Riverside, California, United States, 92503
4
Sunpharma site no. 26
San Diego, California, United States, 92103