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

Phase 2

Completed

• Conditions: Osteoarthritis of Knee
• Interventions: Drug: MM-II dose I; Drug: MM-II dose II; Drug: MM-II dose III; Drug: Placebo

• Registration Number: NCT04506463
• Lead Sponsor: Sun Pharmaceutical Industries Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Study Start: 2020-12-22
• Primary Completion: 2022-05-04
• Study Completion: 2022-08-10
• Disposition First Submitted: 2023-03-29
• Status Verified: 2024-06
• Results First Submitted: 2024-06-17
• Results First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Results First Posted: 2024-08-29
• Disposition First Posted: 2024-08-29
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	MM-II dose I	MM-II 1 ml
Arm B	MM-II dose II	MM-II 3 ml
Arm C	MM-II dose III	MM-II 6 ml
Arm 4	Placebo	Placebo 1ml
Arm 5	Placebo	Placebo 3ml
Arm 6	Placebo	Placebo 6ml

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score	Week 12	The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS	Week 26	Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced. Weekly post-baseline average daily knee pain scores will be calculated.
Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS	Week 26	Global pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of global pain experienced. Weekly post-baseline average daily global pain scores will be calculated

Trial Locations

Locations (25)

Sunpharma site no. 25; 🇺🇸 Riverside, California, United States

Sunpharma site no. 22; 🇺🇸 Miami, Florida, United States

Sunpharma site no. 12; 🇺🇸 Miami, Florida, United States

SunPharma Site no 23; 🇺🇸 Miami, Florida, United States

Sunpharma site no. 26; 🇺🇸 San Diego, California, United States

Sunpharma site no. 20; 🇺🇸 Birmingham, Alabama, United States

SunPharma Site No 24; 🇺🇸 Columbia, South Carolina, United States

Sunpharma site no. 18; 🇺🇸 Flossmoor, Illinois, United States

Sunpharma site no. 06; 🇺🇸 Stamford, Connecticut, United States

Sunpharma site no. 08; 🇺🇸 Lake Worth, Florida, United States

Sunpharma site no. 10; 🇺🇸 Lady Lake, Florida, United States

Sunpharma site no. 13; 🇺🇸 Maitland, Florida, United States

Sunpharma Site no 27; 🇺🇸 Miami, Florida, United States

Sunpharma site no. 05; 🇺🇸 Sunrise, Florida, United States

Sunpharma site no. 04; 🇺🇸 The Villages, Florida, United States

Sunpharma site no. 07; 🇺🇸 Hazelwood, Missouri, United States

Sunpharma site no. 19; 🇺🇸 Edmond, Oklahoma, United States

Sunpharma site no. 17; 🇺🇸 Williamsville, New York, United States

Sunpharma site no. 01; 🇩🇰 Herlev, Denmark

Sunpharma site no. 02; 🇩🇰 Gandrup, Denmark

Sunpharma site no. 21; 🇺🇸 Fort Mill, South Carolina, United States

Sunpharma site no. 03; 🇩🇰 Vejle, Denmark

Sunpharma site no. 14; 🇭🇰 Hong kong, Hong Kong

Sunpharma site no. 11; 🇺🇸 Tempe, Arizona, United States

Sunpharma site no. 09; 🇺🇸 Charleston, South Carolina, United States