Clinical trial NCT04506463: Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of Knee
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
Collaborators: name: Moebius Medical Ltd.
name: Nordic Bioscience Clinical Development (NBCD)
First posted: 2020-08-10
Enrollment: 397
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS
timeFrame: Week 26
measure: Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS
timeFrame: Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sunpharma site no. 20
state: Alabama
city: Tempe
country: United States
facility: Sunpharma site no. 11
state: Arizona
city: Riverside
country: United States
facility: Sunpharma site no. 25
state: California
city: San Diego
country: United States
facility: Sunpharma site no. 26
state: California
city: Stamford
country: United States
facility: Sunpharma site no. 06
state: Connecticut
city: Lady Lake
country: United States
facility: Sunpharma site no. 10
state: Florida
city: Lake Worth
country: United States
facility: Sunpharma site no. 08
state: Florida
city: Maitland
country: United States
facility: Sunpharma site no. 13
state: Florida
city: Miami
country: United States
facility: Sunpharma site no. 22
state: Florida
city: Miami
country: United States
facility: Sunpharma Site no 27
state: Florida
city: Miami
country: United States
facility: Sunpharma site no. 12
state: Florida
city: Miami
country: United States
facility: SunPharma Site no 23
state: Florida
city: Sunrise
country: United States
facility: Sunpharma site no. 05
state: Florida
city: The Villages
country: United States
facility: Sunpharma site no. 04
state: Florida
city: Flossmoor
country: United States
facility: Sunpharma site no. 18
state: Illinois
city: Hazelwood
country: United States
facility: Sunpharma site no. 07
state: Missouri
city: Williamsville
country: United States
facility: Sunpharma site no. 17
state: New York
city: Edmond
country: United States
facility: Sunpharma site no. 19
state: Oklahoma
city: Charleston
country: United States
facility: Sunpharma site no. 09
state: South Carolina
city: Columbia
country: United States
facility: SunPharma Site No 24
state: South Carolina
city: Fort Mill
country: United States
facility: Sunpharma site no. 21
state: South Carolina
city: Gandrup
country: Denmark
facility: Sunpharma site no. 02
city: Herlev
country: Denmark
facility: Sunpharma site no. 01
city: Vejle
country: Denmark
facility: Sunpharma site no. 03
city: Hong kong
country: Hong Kong
facility: Sunpharma site no. 14
Study officials:
References: