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NCT Number: NCT03037489

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

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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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MC Comac Medical, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MIV-711

Drug

MIV-711 administered orally once daily

Primary outcomes

  1. Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients

    Time frame: Group A: 0-56 weeks; Group B: 0-30 weeks

    • Number of Participants with Treatment Emergent Adverse Events (TEAEs)
    • Number of Participants with Serious Adverse Events (SAEs)
    • Number of Participants with TEAEs related to treatment
    • Number of Participants with mild TEAEs
    • Number of Participants with moderate TEAEs
    • Number of Participants with severe TEAEs
    • Number of Participants with TEAEs leading to early discontinuation

Sponsors and collaborators

Lead sponsor

Medivir

Industry

Registry information

Official study title

An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2017
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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