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

March 29, 2023 updated by: Sun Pharmaceutical Industries Limited

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

397

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gandrup, Denmark, 9362
        • Sunpharma site no. 02
      • Herlev, Denmark, 2730
        • Sunpharma site no. 01
      • Vejle, Denmark, 7100
        • Sunpharma site no. 03
  • Hong Kong
      • Hong kong, Hong Kong, 00000
        • Sunpharma site no. 14
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Sunpharma site no. 20
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Sunpharma site no. 11
    • California
      • Riverside, California, United States, 92503
        • Sunpharma site no. 25
      • San Diego, California, United States, 92103
        • Sunpharma site no. 26
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Sunpharma site no. 06
    • Florida
      • Lady Lake, Florida, United States, 32159
        • Sunpharma site no. 10
      • Lake Worth, Florida, United States, 33461
        • Sunpharma site no. 08
      • Maitland, Florida, United States, 32751
        • Sunpharma site no. 13
      • Miami, Florida, United States, 33145
        • Sunpharma site no. 22
      • Miami, Florida, United States, 33155
        • Sunpharma Site no 27
      • Miami, Florida, United States, 33155
        • Sunpharma site no. 12
      • Miami, Florida, United States, 33176
        • SunPharma Site No 23
      • Sunrise, Florida, United States, 33351
        • Sunpharma site no. 05
      • The Villages, Florida, United States, 32159
        • Sunpharma site no. 04
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Sunpharma site no. 18
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Sunpharma site no. 07
    • New York
      • Williamsville, New York, United States, 14221
        • Sunpharma site no. 17
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Sunpharma site no. 19
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Sunpharma site no. 09
      • Columbia, South Carolina, United States, 29206
        • SunPharma Site No 24
      • Fort Mill, South Carolina, United States, 29707
        • Sunpharma site no. 21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
MM-II 1 ml
Drug: MM-II dose I
Intra-articular injection
Experimental: Arm B
MM-II 3 ml
Drug: MM-II dose II
Intra-articular injection
Experimental: Arm C
MM-II 6 ml
Drug: MM-II dose III
Intra-articular injection
Placebo Comparator: Arm 4
Placebo 1ml
Drug: Placebo
Intra-articular injection
Placebo Comparator: Arm 5
Placebo 3ml
Drug: Placebo
Intra-articular injection
Placebo Comparator: Arm 6
Placebo 6ml
Drug: Placebo
Intra-articular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) A pain score
Time Frame: Week 12
The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly average of daily knee pain scores by VAS
Time Frame: Week 26
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.
Week 26
Weekly average of daily global pain scores by VAS
Time Frame: Week 26
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.
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Collaborators

Moebius Medical Ltd.
Nordic Bioscience Clinical Development (NBCD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Actual)

May 4, 2022

Study Completion (Actual)

August 10, 2022

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_17_17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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