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Completed

NCT Number: NCT04506463

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

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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Key information

Conditions

Osteoarthritis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sunpharma site no. 02, Gandrup, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MM-II dose I

Drug

Intra-articular injection

MM-II dose II

Drug

Intra-articular injection

MM-II dose III

Drug

Intra-articular injection

Placebo

Drug

Intra-articular injection

Primary outcomes

  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 outcomes

  1. Change From Baseline in 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 post-baseline average daily knee pain scores will be calculated.

  2. Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS

    Time frame: Week 26

    Global pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of global pain experienced. Weekly post-baseline average daily global pain scores will be calculated

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Collaborators

  • Moebius Medical Ltd.
  • Nordic Bioscience Clinical Development (NBCD)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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