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

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ClinicalTrials.gov Identifier: NCT03037489
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medivir

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: MIV-711 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2016
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: MIV-711
MIV-711 for a total of 26 weeks
Drug: MIV-711
MIV-711 administered orally once daily




Primary Outcome Measures :
  1. Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients [ Time Frame: Group A: 0-56 weeks; Group B: 0-30 weeks ]
    1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)
    2. Number of Participants with Serious Adverse Events (SAEs)
    3. Number of Participants with TEAEs related to treatment
    4. Number of Participants with mild TEAEs
    5. Number of Participants with moderate TEAEs
    6. Number of Participants with severe TEAEs
    7. Number of Participants with TEAEs leading to early discontinuation



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037489


Locations
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Bulgaria
MC Comac Medical
Sofia, Bulgaria
Georgia
LCC ARENSIA Exploratory Medicine
Tbilisi, Georgia
Germany
PAREXEL Berlin Early Phase Clinical Unit
Berlin, Germany
Moldova, Republic of
LCC ARENSIA Exploratory Medicine
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Medivir
Investigators
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Principal Investigator: Philip Conaghan, Professor Leeds Institute of Rheumatic and Musculoskeletal Medicine
  Study Documents (Full-Text)

Documents provided by Medivir:
Study Protocol  [PDF] July 1, 2016
Statistical Analysis Plan  [PDF] January 16, 2018


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Responsible Party: Medivir
ClinicalTrials.gov Identifier: NCT03037489     History of Changes
Other Study ID Numbers: MIV-711-202
First Posted: January 31, 2017    Key Record Dates
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases