drugset / Trial / NCT03658473
Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions
Phase 3
Completed
32 enrolled
Galeno Desenvolvimento de Pesquisas Clínicas
Biolab Sanus Farmaceutica · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This clinical trial evaluated the gastroprotection obtained by the use of rebamipide 300 mg (2x daily) and rabeprazole 20 mg/day (1x daily) associated or not in the prevention of gastric lesions induced by naproxen 1100 mg/day) for 7 days to healthy volunteers of both sexes. This trial also assessed drugs safety and tolerability, the prostaglandin levels (PGE2) in biopsy specimens before and after treatment of each group and the histopathological changes induced by the treatment of each group.
Timeline
- Start
- 2014-11-12
- Primary completion
- 2014-11-27
- Completion
- 2015-02-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rabeprazole | Small molecule | 20 mg | Oral |
| Comparator | Rebamipide | Small molecule | 300 mg | Oral |
| Comparator | Naproxen | Small molecule | 550 mg | Oral |