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NCT Number: NCT02705625

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

This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MC Comac Medical, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric Rating Scale).
  • Inclusive of 40-80 years old.
  • Diagnosis of primary knee osteoarthritis

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.

Treatment and study plan

MIV-711

Drug

MIV-711 administered orally once daily

Placebo

Drug

Placebo manufactured to mimic MIV-711 capsule.

Primary outcomes

  1. Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26

    Time frame: baseline and 26 weeks

    Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score.

    NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".

Secondary outcomes

  1. Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26

    Time frame: baseline and 26 weeks

    Change from Visit 2 (Baseline) to Visit 8 (Week 26) in MRI (Magnetic Resonance Imaging;) bone area of the target knee in mm^2.

  2. Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26

    Time frame: baseline and 26 weeks

    Change from Visit 2 (baseline) to Visit 8 (week 26) in MRI cartilage thickness in the Central Medial Femur Region of the target knee in mm.

  3. Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score

    Time frame: baseline and 26 weeks

    Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC pain score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 5 questions in the WOMAC pain scale which is summed up for the total WOMAC score, leading to a range of 0 to 50. The total WOMAC pain score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):

    • Normalised WOMAC pain score = Total WOMAC pain score multiplicated with 2.

  4. Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score

    Time frame: baseline and 26 weeks

    Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC difficulty score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 17 questions in the WOMAC difficulty scale which is summed up for the total WOMAC difficulty score, leading to a range of 0 to 170. The total WOMAC difficulty score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):

    • Normalised WOMAC difficulty score = Total WOMAC difficulty score divided with 1.7

  5. Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score

    Time frame: baseline and 26 weeks

    Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC stiffness score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 2 questions in the WOMAC stiffness scale which is summed up for the total WOMAC stiffness score, leading to a range of 0 to 20. The total WOMAC stiffness score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):

    • Normalised WOMAC stiffness score = Total WOMAC stiffness score multiplicated with 5

  6. Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26

    Time frame: baseline and 26 weeks

    Change from Visit 2 (baseline) to Visit 8 (week 26) in serum CTX-I, a biomarker for bone resorption.

  7. Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26

    Time frame: baseline and 26 weeks

    Change from Visit 2 (baseline) to Visit 8 (week 26) in creatinine corrected urine CTX-II, a biomarker for cartilage degradation.

Sponsors and collaborators

Lead sponsor

Medivir

Industry

Registry information

Official study title

A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2016
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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