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

M

Medivir

Status and phase

Completed
Phase 2

Conditions

Osteoarthritis, Knee

Treatments

Drug: MIV-711

Study type

Interventional

Funder types

Industry

Identifiers

NCT03037489
MIV-711-202

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

All

Ages

40 to 81 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

MIV-711
Experimental group
Description:
MIV-711 for a total of 26 weeks
Treatment:
Drug: MIV-711

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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