Phase 2
N=397
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
Osteoarthritis of Knee
Bottom Line
View on ClinicalTrials.gov: NCT04506463 ↗Enrolled (actual)
397
Serious AEs
2.8%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score — -1.28; -1.35; -1.14; -0.96 score on a scale — p=0.850
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MM-II dose I (Drug); MM-II dose II (Drug); MM-II dose III (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score |
-1.28; -1.35; -1.14; -0.96; -1.11; -1.10 | 0.850 |
| SECONDARY Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS |
-30.4; -34.5; -23.1; -28.2; -22.7; -30.0 | 0.062 |
| SECONDARY Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS |
-21.0; -22.1; -14.4; -17.6; -12.2; -26.3 | 0.042 sig |
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 Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04506463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.