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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037489
• Other study ID #: MIV-711-202
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

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