A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis

Medivir5 sites in 5 countries244 target enrollmentJanuary 28, 2016

ConditionsOsteoarthritis, Knee

InterventionsMIV-711 Placebo

DrugsMIV-711 Placebo

Overview

Phase: Phase 2
Intervention: MIV-711
Conditions: Osteoarthritis, Knee
Sponsor: Medivir
Enrollment: 244
Locations: 5
Primary Endpoint: Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 28, 2016

End Date

May 23, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medivir

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

MIV-711:1

MIV-711 for a total of 26 w

Intervention: MIV-711

MIV-711:2

MIV-711 for a total of 26 w

Intervention: MIV-711

Placebo

Placebo for a total of 26 w

Intervention: Placebo

Outcomes

Primary Outcomes

Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26

Time Frame: baseline and 26 weeks

Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score. NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".

Secondary Outcomes

Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26(baseline and 26 weeks)
Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26(baseline and 26 weeks)
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score(baseline and 26 weeks)
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score(baseline and 26 weeks)
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score(baseline and 26 weeks)
Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26(baseline and 26 weeks)
Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26(baseline and 26 weeks)