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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
397
Intra-articular injection
Intra-articular injection
Intra-articular injection
Sunpharma site no. 20
Birmingham, Alabama, United States
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score
The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.
Time frame: Week 12
Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS
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.
Time frame: Week 26
Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS
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
Time frame: Week 26
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intra-articular injection
Intra-articular injection
Intra-articular injection
Sunpharma site no. 11
Tempe, Arizona, United States
Sunpharma site no. 25
Riverside, California, United States
Sunpharma site no. 26
San Diego, California, United States
Sunpharma site no. 06
Stamford, Connecticut, United States
Sunpharma site no. 10
Lady Lake, Florida, United States
Sunpharma site no. 08
Lake Worth, Florida, United States
Sunpharma site no. 13
Maitland, Florida, United States
Sunpharma site no. 22
Miami, Florida, United States
Sunpharma Site no 27
Miami, Florida, United States
...and 15 more locations