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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03037489
Other study ID # MIV-711-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2016
Est. completion date November 28, 2017

Study information

Verified date March 2019
Source Medivir
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 28, 2017
Est. primary completion date November 28, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 81 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MIV-711
MIV-711 administered orally once daily

Locations

Country Name City State
Bulgaria MC Comac Medical Sofia
Georgia LCC ARENSIA Exploratory Medicine Tbilisi
Germany PAREXEL Berlin Early Phase Clinical Unit Berlin
Moldova, Republic of LCC ARENSIA Exploratory Medicine Chisinau

Sponsors (1)

Lead Sponsor Collaborator
Medivir

Countries where clinical trial is conducted

Bulgaria,  Georgia,  Germany,  Moldova, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients 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
Group A: 0-56 weeks; Group B: 0-30 weeks
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