90058
document
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 .
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Intervention_Pharmacological
ebrotidine
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Intervention_Pharmacological
ranitidine
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Intervention_Pharmacological
amoxicillin
90062
Intervention_Pharmacological
metronidazole
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Intervention_Pharmacological
ebrotidine
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Intervention_Pharmacological
diaminomethylene
90065
Intervention_Pharmacological
-4-bromo-benzenesulfonamide
90066
Intervention_Pharmacological
ranitidine
90067
Intervention_Pharmacological
amoxicillin
90068
Intervention_Pharmacological
metronidazole
90069
Outcome_Other
eradication
90070
Outcome_Physical
eradication
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Outcome_Physical
demographic parameters
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Outcome_Physical
clinical histories
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Outcome_Physical
eradication
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Outcome_Physical
clinical symptoms
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Outcome_Physical
healing rate
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Participant_Condition
duodenal ulcer
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Participant_Sample-size
two groups of 15