A Study to Evaluate 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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-11-28

Brief Summary

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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).

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIV-711

MIV-711 for a total of 26 weeks

Group Type EXPERIMENTAL

MIV-711

Intervention Type DRUG

MIV-711 administered orally once daily

Interventions

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MIV-711

MIV-711 administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No