Back to resultsA Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MIV-711
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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.
Sites / Locations
- MC Comac Medical
- LCC ARENSIA Exploratory Medicine
- PAREXEL Berlin Early Phase Clinical Unit
- LCC ARENSIA Exploratory Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MIV-711
Arm Description
MIV-711 for a total of 26 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03037489
Brief Title
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
November 28, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivir
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MIV-711
Arm Type
Experimental
Arm Description
MIV-711 for a total of 26 weeks
Intervention Type
Drug
Intervention Name(s)
MIV-711
Intervention Description
MIV-711 administered orally once daily
Primary Outcome Measure Information:
Title
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Description
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
Time Frame
Group A: 0-56 weeks; Group B: 0-30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Conaghan, Professor
Organizational Affiliation
Leeds Institute of Rheumatic and Musculoskeletal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
MC Comac Medical
City
Sofia
Country
Bulgaria
Facility Name
LCC ARENSIA Exploratory Medicine
City
Tbilisi
Country
Georgia
Facility Name
PAREXEL Berlin Early Phase Clinical Unit
City
Berlin
Country
Germany
Facility Name
LCC ARENSIA Exploratory Medicine
City
Chisinau
Country
Moldova, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
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