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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE January 31, 2017
Results First Submitted Date  ICMJE November 26, 2018
Results First Posted Date  ICMJE March 18, 2019
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Safety and tolerability of MIV-711 in OA patients [ Time Frame: 26 weeks ]
  1. AE/SAE
    1. measuring the number of AEs
    2. summarizing the severities of AEs
    3. measuring the number of AEs related to treatment
    4. summarizing the severities of AEs related to treatment
    5. measuring the number and severity of SAEs
    6. measuring the number and severity of SAEs related to treatment
  2. Labs
    1. Number of abnormals
    2. Number of grade 3 or 4 (if grading lab results)
    3. Change from baseline
  3. ECGS
    1. Number of abnormals
    2. Change from baseline
    3. Number of pts with prolonged QTc
    4. Etc
  4. PE
    1. Number of abnormals
    2. Change from baseline
  5. Vitals
    1. BP
    2. Heart rate
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Official Title  ICMJE An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Drug: MIV-711
MIV-711 administered orally once daily
Study Arms  ICMJE Experimental: MIV-711
MIV-711 for a total of 26 weeks
Intervention: Drug: MIV-711
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
80
Actual Study Completion Date  ICMJE November 28, 2017
Actual Primary Completion Date November 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Georgia,   Germany,   Moldova, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03037489
Other Study ID Numbers  ICMJE MIV-711-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medivir
Study Sponsor  ICMJE Medivir
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Conaghan, Professor Leeds Institute of Rheumatic and Musculoskeletal Medicine
PRS Account Medivir
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP