A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Patients With Knee Osteoarthritis
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 40 - 75 |
Updated: | 3/9/2019 |
Start Date: | August 14, 2018 |
End Date: | December 2020 |
Contact: | Evelyn Fox |
Email: | evelyn.fox@glpg.com |
Phone: | 0032 15 34 29 00 |
Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
This study is a phase 2, 52-week international, multi-regional, multicenter, randomized,
double-blind, placebo-controlled dose-ranging study for the treatment of Osteoarthritis.
double-blind, placebo-controlled dose-ranging study for the treatment of Osteoarthritis.
Inclusion Criteria:
- Male patients or female patients of non-childbearing potential Age between 40 to 75
years (both inclusive).
- 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.
- Symptom 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
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).
- Surgical operation on the target knee within the 12 months prior to the screening
visit or planned during the study.
- Arthroscopy of the target knee within the 6 months prior to the screening visit or
planned during the study.
- Other pathologies affecting the 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.
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770 Washington Street
San Diego, California 92103
San Diego, California 92103
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