NCT04506463

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

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Single-administration, Multiple-Dose Study to Demonstrate the Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 40 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of Knee

Interventions

Type	Name	Description
DRUG	MM-II dose I	Intra-articular injection
DRUG	MM-II dose II	Intra-articular injection
DRUG	MM-II dose III	Intra-articular injection
DRUG	Placebo	Intra-articular injection
DRUG	Placebo	Intra-articular injection
DRUG	Placebo	Intra-articular injection

Timeline

• Start date: 2020-12-22
• Primary completion: 2022-05-04
• Completion: 2022-08-10
• First posted: 2020-08-10
• Last updated: 2024-08-29
• Results posted: 2024-08-29

Locations

25 sites across 3 countries: United States, Denmark, Hong Kong

Regulatory

• FDA-regulated drug study