Abstract | BACKGROUND/AIMS: METHODOLOGY: This multicenter, randomized, double-blind study involved 648 duodenal ulcer patients and had been carried out to compare the following regimens: ranitidine bismuth citrate b.i.d. co-prescribed with either clarithromycin 250 mg q.i.d. or clarithromycin 500 mg b.i.d. or clarithromycin 500 mg b.i.d. plus metronidazole 400 mg b.i.d. for 2 weeks, followed by a further 14 days of treatment with ranitidine bismuth citrate 400 mg b.i.d. to facilitate ulcer healing. H. pylori eradication was assessed by 13C-urea breath test and histology at least 4 weeks, 26 weeks and 52 weeks after the end of treatment. Ulcer relapse and H. pylori status were assessed 4 weeks, 26 weeks and 52 weeks post-treatment or if ulcer symptoms recurred. For the remainder of the follow-up period only serious adverse events were collected. RESULTS: At 12 months data of 438 (69%) patients were evaluable. The observed H. pylori eradication rates were 88-91%. H. pylori relapse rates were 2.1% after 26 weeks and 3.9% after 52 weeks. At the week 26 visit 26 patients (5.6%) and at the week 52 visit 25 patients (5.7%) had documented gastroesophageal reflux disease. CONCLUSIONS:
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Authors | H Wurzer, K D Bardhan, M Marcelino, J Jahnsen, M Allmaier |
Journal | Hepato-gastroenterology
(Hepatogastroenterology)
2001 Nov-Dec
Vol. 48
Issue 42
Pg. 1641-7
ISSN: 0172-6390 [Print] Greece |
PMID | 11813591
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Anti-Bacterial Agents
- Metronidazole
- ranitidine bismuth citrate
- Ranitidine
- Clarithromycin
- Bismuth
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Anti-Bacterial Agents
(administration & dosage, therapeutic use)
- Bismuth
(therapeutic use)
- Clarithromycin
(administration & dosage, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Duodenal Ulcer
(drug therapy, microbiology)
- Helicobacter Infections
(drug therapy)
- Helicobacter pylori
- Humans
- Metronidazole
(administration & dosage, therapeutic use)
- Middle Aged
- Ranitidine
(analogs & derivatives, therapeutic use)
- Secondary Prevention
- Treatment Outcome
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