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

Medivir

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Placebo; Drug: MIV-711

Study type: Interventional

Funder types: Industry

Identifiers

NCT02705625

MIV-711-201

Details and patient eligibility

About

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).

Enrollment: 244 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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244 participants in 3 patient groups, including a placebo group

MIV-711:1

Experimental group

Description:

MIV-711 for a total of 26 w

Treatment:

Drug: MIV-711

MIV-711:2

Experimental group

Description:

MIV-711 for a total of 26 w

Treatment:

Drug: MIV-711

Placebo

Placebo Comparator group

Description:

Placebo for a total of 26 w

Treatment:

Drug: Placebo