A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients

Summary

This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).

Timeline

Start

2016-01-28

Primary completion

2017-05-23

Completion

2017-05-23

Outcome

Missed primary endpoint

registry analysis (superiority test); MIV-711:200 mg vs Placebo; p = 0.4055; Mean Difference (Final Values) -0.0761 (95% CI -0.703 to 0.55); Mixed Models Analysis NCT02705625 ↗

release “MIV-711 did not show a statistically significant effect on patient-reported numerical rating scale (NRS) pain following 6 months of treatment, the primary endpoint of the study.” medivir.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MIV-711	Unknown	—	Oral

Indications