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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-28

Study Completion Date

2017-05-23

Brief Summary

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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).

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MIV-711:1

MIV-711 for a total of 26 w

Group Type EXPERIMENTAL

MIV-711

Intervention Type DRUG

MIV-711 administered orally once daily

MIV-711:2

MIV-711 for a total of 26 w

Group Type EXPERIMENTAL

MIV-711

Intervention Type DRUG

MIV-711 administered orally once daily

Placebo

Placebo for a total of 26 w

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo manufactured to mimic MIV-711 capsule.

Interventions

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MIV-711

MIV-711 administered orally once daily

Intervention Type DRUG

Placebo

Placebo manufactured to mimic MIV-711 capsule.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No