A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
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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
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Sponsor:
Medivir
Information provided by (Responsible Party):
Medivir
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Osteoarthritis, Knee |
Intervention |
Drug: MIV-711 |
Enrollment | 50 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Group A | Group B |
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Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 (NCT02705625) and whose symptoms did not clinically significantly deteriorate as defined by an increase in the Numeric Rating Scale (NRS) of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. | Study Group B was recruited from patients receiving placebo in Study MIV-711-201 (NCT02705625) having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. |
Period Title: Overall Study | ||
Started | 46 | 4 |
Completed | 39 | 4 |
Not Completed | 7 | 0 |
Reason Not Completed | ||
Adverse Event | 4 | 0 |
Withdrawal by Subject | 3 | 0 |
Baseline Characteristics
Arm/Group Title | Group A | Group B | Total | |
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Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. | Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 46 | 4 | 50 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 46 participants | 4 participants | 50 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
30 65.2%
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2 50.0%
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32 64.0%
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>=65 years |
16 34.8%
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2 50.0%
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18 36.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 46 participants | 4 participants | 50 participants | |
61.5 (7.52) | 65.5 (5.51) | 61.8 (7.42) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 46 participants | 4 participants | 50 participants | |
Female |
31 67.4%
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3 75.0%
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34 68.0%
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Male |
15 32.6%
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1 25.0%
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16 32.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 46 participants | 4 participants | 50 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
46 100.0%
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4 100.0%
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50 100.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 46 participants | 4 participants | 50 participants |
Moldova | 21 | 3 | 24 | |
Georgia | 3 | 0 | 3 | |
Bulgaria | 9 | 0 | 9 | |
Germany | 13 | 1 | 14 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Linda Basse, Cheif Medical Officer |
Organization: | Medivir AB |
Phone: | +46 8 546 831 00 |
EMail: | linda.basse@medivir.com |
Responsible Party: | Medivir |
ClinicalTrials.gov Identifier: | NCT03037489 |
Other Study ID Numbers: |
MIV-711-202 |
First Submitted: | December 22, 2016 |
First Posted: | January 31, 2017 |
Results First Submitted: | November 26, 2018 |
Results First Posted: | March 18, 2019 |
Last Update Posted: | March 18, 2019 |