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

Medivir

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis, Knee

Treatments

Drug: MIV-711

Study type

Interventional

Funder types

Industry

Identifiers

NCT03037489

MIV-711-202

Details and patient eligibility

About

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).

Enrollment

50 patients

Sex

All

Ages

40 to 81 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by

Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by
Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2

Exclusion criteria

The presence of any inflammatory arthritis
Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.