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

Sun Pharma

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of Knee

Treatments: Drug: MM-II dose II; Drug: MM-II dose I; Drug: Placebo; Drug: MM-II dose III

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04506463

CLR_17_17

Details and patient eligibility

About

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.

Enrollment: 397 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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397 participants in 6 patient groups, including a placebo group

Arm A

Experimental group

Description:

MM-II 1 ml

Treatment:

Drug: MM-II dose I

Arm B

Experimental group

Description:

MM-II 3 ml

Treatment:

Drug: MM-II dose II

Arm C

Experimental group

Description:

MM-II 6 ml

Treatment:

Drug: MM-II dose III

Arm 4

Placebo Comparator group

Description:

Placebo 1ml

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Arm 5

Placebo Comparator group

Description:

Placebo 3ml

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Arm 6

Placebo Comparator group

Description:

Placebo 6ml

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo