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

NCT ID: NCT04506463

Last Updated: 2024-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2022-08-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

MM-II 1 ml

Group Type EXPERIMENTAL

MM-II dose I

Intervention Type DRUG

Intra-articular injection

Arm B

MM-II 3 ml

Group Type EXPERIMENTAL

MM-II dose II

Intervention Type DRUG

Intra-articular injection

Arm C

MM-II 6 ml

Group Type EXPERIMENTAL

MM-II dose III

Intervention Type DRUG

Intra-articular injection

Arm 4

Placebo 1ml

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intra-articular injection

Arm 5

Placebo 3ml

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intra-articular injection

Arm 6

Placebo 6ml

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intra-articular injection

Interventions

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MM-II dose I

Intra-articular injection

Intervention Type DRUG

MM-II dose II

Intra-articular injection

Intervention Type DRUG

MM-II dose III

Intra-articular injection

Intervention Type DRUG

Placebo

Intra-articular injection

Intervention Type DRUG

Placebo

Intra-articular injection

Intervention Type DRUG

Placebo

Intra-articular injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moebius Medical Ltd.

INDUSTRY

Sponsor Role collaborator

Nordic Bioscience Clinical Development (NBCD)

UNKNOWN

Sponsor Role collaborator

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sunpharma site no. 20

Birmingham, Alabama, United States

Site Status

Sunpharma site no. 11

Tempe, Arizona, United States

Site Status

Sunpharma site no. 25

Riverside, California, United States

Site Status

Sunpharma site no. 26

San Diego, California, United States

Site Status

Sunpharma site no. 06

Stamford, Connecticut, United States

Site Status

Sunpharma site no. 10

Lady Lake, Florida, United States

Site Status

Sunpharma site no. 08

Lake Worth, Florida, United States

Site Status

Sunpharma site no. 13

Maitland, Florida, United States

Site Status

Sunpharma site no. 22

Miami, Florida, United States

Site Status

Sunpharma Site no 27

Miami, Florida, United States

Site Status

Sunpharma site no. 12

Miami, Florida, United States

Site Status

SunPharma Site no 23

Miami, Florida, United States

Site Status

Sunpharma site no. 05

Sunrise, Florida, United States

Site Status

Sunpharma site no. 04

The Villages, Florida, United States

Site Status

Sunpharma site no. 18

Flossmoor, Illinois, United States

Site Status

Sunpharma site no. 07

Hazelwood, Missouri, United States

Site Status

Sunpharma site no. 17

Williamsville, New York, United States

Site Status

Sunpharma site no. 19

Edmond, Oklahoma, United States

Site Status

Sunpharma site no. 09

Charleston, South Carolina, United States

Site Status

SunPharma Site No 24

Columbia, South Carolina, United States

Site Status

Sunpharma site no. 21

Fort Mill, South Carolina, United States

Site Status

Sunpharma site no. 02

Gandrup, , Denmark

Site Status

Sunpharma site no. 01

Herlev, , Denmark

Site Status

Sunpharma site no. 03

Vejle, , Denmark

Site Status

Sunpharma site no. 14

Hong Kong, , Hong Kong

Site Status

Countries

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United States Denmark Hong Kong

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLR_17_17

Identifier Type: -

Identifier Source: org_study_id

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