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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03037489 |
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Date of registration:
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22/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
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Scientific title:
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An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03037489 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Bulgaria
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Georgia
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Germany
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Moldova, Republic of
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Contacts
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Name:
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Philip Conaghan, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Leeds Institute of Rheumatic and Musculoskeletal Medicine |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
81 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Drug: MIV-711
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Primary Outcome(s)
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Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
[Time Frame: Group A: 0-56 weeks; Group B: 0-30 weeks]
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Secondary ID(s)
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MIV-711-202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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