A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Arthritis Non-Inferiority Study of LT-NS001 versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates
- Registry ID
- EUCTR2009-018029-57
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE2
- Sponsor
- Logical Therapeutics Inc.
- Start date
- 2010-04-09
- Completion date
- 2010-12-08
- Last update
- 2026-08-16
Conditions
- osteoarthritis of the knee
Summary
Primary (GI Safety): To compare the cumulative incidence of patients with gastric ulcer by endoscopy (EGD) for Arm A vs Arm B Secondary (for Arm A vs Arm B): 1. To demonstrate non-inferior pain control in an index osteoarthritic knee joint 2. To compare overall gastric injury rates by EGD 3. To compare tolerability and retention on study drug
Locations
View on source registry