At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 626 enrolled
Drug / intervention
MT-5547 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
In Brief
A Phase 3 clinical trial evaluating MT-5547 and MT-5547-matching placebo for Osteoarthritis, Knee / Osteoarthritis, Hip. Completed, enrolled 626 participants across 27 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionDec 2019
Study CompletionMar 2021
TodayJul 2026
First PostedAug 10, 2017
Enrollment StartSep 8, 2017
Primary CompletionDec 14, 2019
Study CompletionMar 9, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.9 years ago
Interventions
MT-5547drug
Solution for injection in pre-filled syringe
MT-5547-matching placebodrug
Solution for injection in pre-filled syringe