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Trial record 1 of 5 for:    MM-II
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Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04506463
Recruitment Status : Not yet recruiting
First Posted : August 10, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Moebius Medical Ltd.
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Knee Drug: MM-II dose I Drug: MM-II dose II Drug: MM-II dose III Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506463


Contacts
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Contact: Head Clinical Development 912266455645 clinical.trials@sparcmail.com

Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Moebius Medical Ltd.
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Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT04506463    
Other Study ID Numbers: CLR_17_17
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases