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

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.

Timeline

Start

2020-12-22

Primary completion

2022-05-04

Completion

2022-08-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm B: MM-II 3 ml vs Arm 5: Placebo 3 ml; p = 0.085; Mixed Models Analysis NCT04506463 ↗

release “primary endpoi nt) was larger for MM-II 3 mL vs placebo 3 mL ( nominal P = 0.047; adjusted for multiplicity, P = 0.085” sunpharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MM-II	Unknown	1 ml	Other
Subject	MM-II	Unknown	3 ml	Other
Subject	MM-II	Unknown	6 ml	Other

Indications