NCT03245008

Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 626 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.

Detailed description

The blind will be maintained, including for the study sponsor, until the key code is opened after the data have been fixed for all subjects in Week 24. In addition, in order to eliminate any bias that could affect the study assessments, to the extent possible, the blind will be maintained with respect to the study site and the subject even after the opening of the study sponsor key code.

Conditions

• Osteoarthritis, Knee / Osteoarthritis, Hip

Interventions

Type	Name	Description
DRUG	MT-5547	Solution for injection in pre-filled syringe
DRUG	MT-5547-matching placebo	Solution for injection in pre-filled syringe

Timeline

• Start date: 2017-09-08
• Primary completion: 2019-12-14
• Completion: 2021-03-09
• First posted: 2017-08-10
• Last updated: 2026-01-07
• Results posted: 2023-05-17

Locations

27 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study