위궤양에 대한 레바프라잔 정제의 제3상 임상시험open accessPhase III Clinical Trial of Revaprazan (Revanex?) for Gastric Ulcer
- Other Titles
- Phase III Clinical Trial of Revaprazan (Revanex?) for Gastric Ulcer
- Authors
- 장린; 주상언; 정인식; 박수헌; 김성국; 최석렬; 송근암; 함기백; 이용찬; 김현수; 김태년; 최석채; 설상영; 유종선; 김동준; 이진; 최호순; 이정은; 송근석; 문병석
- Issue Date
- Dec-2007
- Publisher
- 대한소화기내시경학회
- Keywords
- 레바프라잔; 오메프라졸; 위궤양; 3상시험; Revaprazan; Omeprazole; Gastric ulcer; Clinical trial phase III
- Citation
- Clinical Endoscopy, v.34, no.6, pp.312 - 319
- Indexed
- KCI
- Journal Title
- Clinical Endoscopy
- Volume
- 34
- Number
- 6
- Start Page
- 312
- End Page
- 319
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/179203
- ISSN
- 2234-2400
- Abstract
- Background/Aims: This randomized, double-blind, phase III, multicenter trial was carried out to compare the efficacy and safety of revaprazan, a novel acid pump antagonist, with that of omeprazole in patients with more than one of gastric ulcers. Methods: Two hundred and ninety two subjects were randomized to 4∼8 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg. The primary efficacy parameter was the cumulative healing rate determined by endoscopy after 4 and 8 weeks of treatment, and the secondary efficacy parameter was an improvement rate of pain. Results: The intention-to-treat analysis revealed revaprazan and omeprazole to have similar cumulative healing rates (93.0% and 89.6%, respectively; p=0.3038). The per-protocol analysis revealed revaprazan and omeprazole to also have similar cumulative healing rates (99.1% and 100%, respectively; p= 0.3229). In both analyses, there were no significant differences in an improvement rate of pain between the two groups. Both drugs were well tolerated. Conclusions: Revaprazan has similar efficacy to omeprazole in the treatment of patients with gastric ulcer with a once a day application of revaprazan 200 mg or omeprazole 20 mg over a 4 to 8-week period. In terms of safety, revaprazan was well tolerated.
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