Back to resultsEfficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
Primary Purpose
Osteoarthritis of Knee
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MM-II dose I
MM-II dose II
MM-II dose III
Placebo
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee
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
Sites / Locations
- Sunpharma site no. 20
- Sunpharma site no. 11
- Sunpharma site no. 25
- Sunpharma site no. 26
- Sunpharma site no. 06
- Sunpharma site no. 10
- Sunpharma site no. 08
- Sunpharma site no. 13
- Sunpharma site no. 22
- Sunpharma Site no 27
- Sunpharma site no. 12
- SunPharma Site no 23
- Sunpharma site no. 05
- Sunpharma site no. 04
- Sunpharma site no. 18
- Sunpharma site no. 07
- Sunpharma site no. 17
- Sunpharma site no. 19
- Sunpharma site no. 09
- SunPharma Site No 24
- Sunpharma site no. 21
- Sunpharma site no. 02
- Sunpharma site no. 01
- Sunpharma site no. 03
- Sunpharma site no. 14
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Arm A
Arm B
Arm C
Arm 4
Arm 5
Arm 6
Arm Description
MM-II 1 ml
MM-II 3 ml
MM-II 6 ml
Placebo 1ml
Placebo 3ml
Placebo 6ml
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 average of daily global 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.
Full Information
NCT ID
NCT04506463
First Posted
August 6, 2020
Last Updated
March 29, 2023
Sponsor
Sun Pharmaceutical Industries Limited
Collaborators
Moebius Medical Ltd., Nordic Bioscience Clinical Development (NBCD)
1. Study Identification
Unique Protocol Identification Number
NCT04506463
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited
Collaborators
Moebius Medical Ltd., Nordic Bioscience Clinical Development (NBCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
MM-II 1 ml
Arm Title
Arm B
Arm Type
Experimental
Arm Description
MM-II 3 ml
Arm Title
Arm C
Arm Type
Experimental
Arm Description
MM-II 6 ml
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
Placebo 1ml
Arm Title
Arm 5
Arm Type
Placebo Comparator
Arm Description
Placebo 3ml
Arm Title
Arm 6
Arm Type
Placebo Comparator
Arm Description
Placebo 6ml
Intervention Type
Drug
Intervention Name(s)
MM-II dose I
Intervention Description
Intra-articular injection
Intervention Type
Drug
Intervention Name(s)
MM-II dose II
Intervention Description
Intra-articular injection
Intervention Type
Drug
Intervention Name(s)
MM-II dose III
Intervention Description
Intra-articular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intra-articular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intra-articular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intra-articular injection
Primary Outcome Measure Information:
Title
Change from Baseline in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) A pain score
Description
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
Secondary Outcome Measure Information:
Title
Weekly average of daily knee pain scores by VAS
Description
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.
Time Frame
Week 26
Title
Weekly average of daily global pain scores by VAS
Description
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.
Time Frame
Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sunpharma site no. 20
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Sunpharma site no. 11
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Sunpharma site no. 25
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Sunpharma site no. 26
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sunpharma site no. 06
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Sunpharma site no. 10
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Sunpharma site no. 08
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Sunpharma site no. 13
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Sunpharma site no. 22
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Sunpharma Site no 27
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Sunpharma site no. 12
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
SunPharma Site no 23
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Sunpharma site no. 05
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Sunpharma site no. 04
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Sunpharma site no. 18
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Sunpharma site no. 07
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Sunpharma site no. 17
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Sunpharma site no. 19
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Sunpharma site no. 09
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
SunPharma Site No 24
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Sunpharma site no. 21
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Sunpharma site no. 02
City
Gandrup
ZIP/Postal Code
9362
Country
Denmark
Facility Name
Sunpharma site no. 01
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Sunpharma site no. 03
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Sunpharma site no. 14
City
Hong kong
ZIP/Postal Code
00000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
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