Abstract | OBJECTIVE: METHODS: In this multicentre Canadian trial, H pylori-positive patients with functional dyspepsia or inactive peptic ulcer disease were randomized to open-label treatment with RBC-C ( ranitidine bismuth citrate 400 mg plus clarithromycin 500 mg) or OCA (omezaprole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg), given twice a day for seven days. Treatment allocation was randomly assigned. H pylori infection was confirmed by positive 13C-urea breath test (13C-UBT). H pylori status was reassessed by UBT at least four and 12 weeks after treatment (negative: d13CO2 below 3.5 per mil). Intention-to-treat (ITT) eradication rates were determined for all patients with confirmed H pylori infection. Per protocol (PP) rate was determined for all patients treated with at least two evaluable follow-up visits. RESULTS: Three hundred five patients were included in the ITT and 222 in the PP analysis. The ITT eradication rates were 66% for RBC-C and 78% for OCA. The PP success rates were 84% for RBC-C and 96% for OCA. The difference for both ITT 12% (95% CI 2 to 22) and PP 12% (95% CI 4 to 19) were statistically significant, P=0.030 and P=0.007, respectively. Treatment was generally well tolerated. CONCLUSION: The eradication rate for the seven-day dual RBC-C regimen was lower than that for OCA.
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Authors | Sander Veldhuyzen van Zanten, Naoki Chiba, Alan Barkun, Carlo Fallone, Alain Farley, Alan Cockeram, Chrystian Dallaire, Lorinda Simms, Barbara Nicholls |
Journal | Canadian journal of gastroenterology = Journal canadien de gastroenterologie
(Can J Gastroenterol)
Vol. 17
Issue 9
Pg. 533-8
(Sep 2003)
ISSN: 0835-7900 [Print] Canada |
PMID | 14532926
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Anti-Ulcer Agents
- ranitidine bismuth citrate
- Amoxicillin
- Ranitidine
- Urea
- Clarithromycin
- Omeprazole
- Bismuth
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Topics |
- Amoxicillin
(therapeutic use)
- Anti-Bacterial Agents
(therapeutic use)
- Anti-Ulcer Agents
(therapeutic use)
- Bismuth
(therapeutic use)
- Breath Tests
- Clarithromycin
(therapeutic use)
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Helicobacter Infections
(diagnosis, drug therapy)
- Helicobacter pylori
- Humans
- Male
- Middle Aged
- Omeprazole
(therapeutic use)
- Patient Satisfaction
- Ranitidine
(analogs & derivatives, therapeutic use)
- Time Factors
- Urea
(analysis)
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