Trial record 1 of 5 for:
MM-II
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis
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| ClinicalTrials.gov Identifier: NCT04506463 |
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Recruitment Status :
Recruiting
First Posted : August 10, 2020
Last Update Posted : October 28, 2021
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Sponsor:
Sun Pharmaceutical Industries Limited
Collaborator:
Moebius Medical Ltd.
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 348 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 |
| Actual Study Start Date : | December 22, 2020 |
| Estimated Primary Completion Date : | November 2021 |
| Estimated Study Completion Date : | November 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A
MM-II 1 ml
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Drug: MM-II dose I
Intra-articular injection |
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Experimental: Arm B
MM-II 3 ml
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Drug: MM-II dose II
Intra-articular injection |
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Experimental: Arm C
MM-II 6 ml
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Drug: MM-II dose III
Intra-articular injection |
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Placebo Comparator: Arm 4
Placebo 1ml
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Drug: Placebo
Intra-articular injection |
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Placebo Comparator: Arm 5
Placebo 3ml
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Drug: Placebo
Intra-articular injection |
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Placebo Comparator: Arm 6
Placebo 6ml
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Drug: Placebo
Intra-articular injection |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
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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:
- 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
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
| Contact: Head Clinical Development | 912266455645 | clinical.trials@sparcmail.com |
Locations
Show 25 study locations
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Moebius Medical Ltd.
| 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: | October 28, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |