Efficacy of S201086/GLPG1972 in patients with knee osteoarthritis

Phase 1

• Conditions: Osteoarthritis; MedDRA version: 20.0Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-004581-10-PL
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-21
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 852

Inclusion Criteria

Male patients or female patients of non-childbearing potential
Age between 40 to 75 years (both inclusive) for male patients and female surgically sterile patients, and 50 to 75 years (both inclusive) for postmenopausal female patients
Body weight > 40 kg, body mass index (BMI) < 40 kg/m2
Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology
History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month
Symptoms severity defined by a pain = 40 mm and = 90 mm on VAS (100 mm)
Documented need for symptomatic as needed-treatment for OA in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 502
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

Severe clinical knee malalignment according to the investigator
Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side)
Knee prosthesis already foreseen within the study period (whichever side)
Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side)
Previous osteotomy on the inferior limbs (whichever side) other than intervention for hallux valgus with full clinical recovery after surgery
Any surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study
Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study
Other current or medical history pathologies affecting the target knee
Any contraindication to MRI including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil, or the presence of pacemaker or any other implanted electronic devices

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified