Phase 2
Completed N=50
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03037489 ↗
Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Mar 2019
Primary outcomePrimary: Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients — 21; 2; 2; 0 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients |
21; 2; 2; 0; 1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03037489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.