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

• Status: Completed
• Trial end date: 2017-05-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivir

Criteria

Inclusion Criteria:

• Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric Rating Scale).

• Inclusive of 40-80 years old.

• Diagnosis of primary knee osteoarthritis

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.