Efficacy of ebrotidine and ranitidine combined with amoxicillin and metronidazole in the eradication of Helicobacter pylori in patients with duodenal ulcer.
This double-blind, randomized, phase III clinical trial was carried out in two parallel groups to assess the efficacy of ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene) amino]-4-thiazolyl]methyl]thio]ethyl]amino] methylene]-4-bromo-benzenesulfonamide, CAS 100981-43-9, FI-3542) 400 mg and ranitidine 300 mg given in single evening dose, combined with amoxicillin 750 mg and metronidazole 500 mg three times daily for 14 days, in the eradication of Helicobacter pylori in patients with duodenal ulcer. Thirty patients were included, divided into two groups of 15, to whom one of the study therapies was administered based on a randomization code. Clinical and endoscopic controls were performed 4, 6 and 8 weeks after the onset of the treatment. No differences were seen between the two treatment groups with regard to demographic parameters and clinical histories. They were both perfectly homogeneous. There were no differences between the eradication of both therapies in both the antrum and gastric body samples (over 80% eradication), allowing the results to be classified as satisfactory. Moreover, perfect control was achieved through the study of clinical symptoms, which even disappeared in some cases. There were no differences in the healing rate of the duodenal ulcer after four weeks, 86.7% being achieved for both groups.
Popiela
T
T
1st Department of General and Gastrointestinal Surgery, Jagiellonian University, Krakow, Poland.
Kulig
J
J
Karcz
D
D
Tabor
J
J
Torres
J
J
Márquez
M
M
Fillat
O
O
Herrero
E
E
Ortiz
J A
JA
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D005756:Gastritis / Q000188:drug therapy; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D011899:Ranitidine / Q000627:therapeutic use*; D013844:Thiazoles / Q000627:therapeutic use*
D001557:Benzenesulfonates; D006635:Histamine H2 Antagonists; D013844:Thiazoles; D008795:Metronidazole; D000658:Amoxicillin; D011899:Ranitidine; C075156:ebrotidine