Trial record 1 of 6 for:
MM-II
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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04506463 |
|
Recruitment Status :
Completed
First Posted : August 10, 2020
Last Update Posted : September 13, 2022
|
Sponsor:
Sun Pharmaceutical Industries Limited
Collaborators:
Moebius Medical Ltd.
Nordic Bioscience Clinical Development (NBCD)
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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) |
| Actual Enrollment : | 397 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 |
| Actual Primary Completion Date : | May 4, 2022 |
| Actual Study Completion Date : | August 10, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
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 :
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
Locations
Show 25 study locations
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Moebius Medical Ltd.
Nordic Bioscience Clinical Development (NBCD)
| 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: | September 13, 2022 |
| Last Verified: | June 2022 |
| 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:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |