CompletedPhase 2/3

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

Japan626 participantsStarted 2017-09-08

Plain-language 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.

Who can participate

Age range40 Years – 85 Years

SexALL

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Inclusion criteria

✓. Inadequate OA pain relief from at least 1 oral NSAID.
✓. Intolerance to or inadequate OA pain relief from at least 1 opioid (including combination drugs), or unwillingness to take opioid therapy.

What they're measuring

WOMAC Pain Score (Change From Baseline at Week 16)

Timeframe: Baseline to Week 16

Trial details

NCT IDNCT03245008

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-14

Results submitted2023-03-08

View on ClinicalTrials.gov More Osteoarthritis, Knee / Osteoarthritis, Hip trials