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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705625
• Other study ID #: MIV-711-201
• Status: Completed
• Phase: Phase 2
• Start date: January 28, 2016
• Est. completion date: May 23, 2017

Study information

• Verified date: March 2019
• Source: Medivir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• MIV-711
MIV-711 administered orally once daily
• Placebo
Placebo manufactured to mimic MIV-711 capsule.

Locations

Country	Name	City	State
Bulgaria	MC Comac Medical	Sofia
Georgia	LCC ARENSIA Exploratory Medicine	Tbilisi
Germany	PAREXEL Berlin Early Phase Clinical Unit	Berlin
Moldova, Republic of	LCC ARENSIA Exploratory Medicine	Chisinau
Romania	SC ARENSIA Exploratory Medicine SRL	Bucharest
United Kingdom	University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Medivir

Countries where clinical trial is conducted

Bulgaria,  Georgia,  Germany,  Moldova, Republic of,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26	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".	baseline and 26 weeks
Secondary	Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26	Change from Visit 2 (Baseline) to Visit 8 (Week 26) in MRI (Magnetic Resonance Imaging;) bone area of the target knee in mm^2.	baseline and 26 weeks
Secondary	Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26	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.	baseline and 26 weeks
Secondary	Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score	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.	baseline and 26 weeks
Secondary	Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score	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	baseline and 26 weeks
Secondary	Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score	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	baseline and 26 weeks
Secondary	Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26	Change from Visit 2 (baseline) to Visit 8 (week 26) in serum CTX-I, a biomarker for bone resorption.	baseline and 26 weeks
Secondary	Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26	Change from Visit 2 (baseline) to Visit 8 (week 26) in creatinine corrected urine CTX-II, a biomarker for cartilage degradation.	baseline and 26 weeks