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document
Comparison of the efficacy and safety of ebrotidine in the treatment of duodenal ulcer . A multicentre , double-blind , placebo-controlled phase II study . Ebrotidine ( N- [ ( E ) - [ [ 2- [ [ [ 2- [ ( diaminomethylene ) amino ] -4 -thiazoly ] methyl ] thio ] ethyl ] amino ] methylene ] -4-bromo-benzenesulfon amide , CAS 100981-43-9 , FI-3542 ) is a new H2-receptor antagonist characterized by its high receptor affinity and gastroprotective effect . This Phase II study has been undertaken to establish the efficacy and safety of ebrotidine , administered in four dosages as a single evening dose versus placebo in the treatment of duodenal ulcer . A total of 110 duodenal ulcer patients were studied in a randomized , double-blind , placebo-controlled , multicentre clinical trial . The patients were assigned to 5 groups : placebo , 200 mg , 400 mg , 600 mg and 800 mg of ebrotidine once daily . Controls were performed at baseline and every two weeks at four follow-up visits unless ulcer healed before . Endoscopic examination was the main parameter for the assessment of treatment efficacy and ulcer healing rate . Vital signs and blood/ urine analysis were used to establish safety . The three groups treated with higher dosages ( 400 to 800 mg of ebrotidine daily ) showed an endoscopic ulcer healing rate of 90-95 % , significantly higher than 55 % achieved with placebo ( p < 0.05 ) , whilst the differences between these three dosages of ebrotidine were not statistically significant . Healing rate in the group treated with 200 mg of ebrotidine daily was not significantly different from that in the placebo group . The development of symptoms , number of episodes of ulcer-related pain , total ulcerated surface area or subjective ratings by the patients and investigators also differed significantly between ebrotidine ( 400 , 600 and 800 mg daily ) and placebo , and again , no marked differences were found between these three doses of ebrotidine . As far as tolerance is concerned , no clinically or statistically significant changes were observed in vital signs and analytical parameters . The incidence of side effects was less than that presented by the placebo group , possibly due to a greater consumption of antacids in this group . Results showed that a daily dose of 400 mg ebrotidine is effective and safe in the treatment of duodenal ulcers .
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Intervention_Pharmacological
ebrotidine
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Intervention_Control
placebo
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Intervention_Physical
placebo
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Intervention_Pharmacological
200 mg , 400 mg , 600 mg and 800 mg of ebrotidine
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Outcome_Other
efficacy and safety
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Outcome_Other
efficacy and safety
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Outcome_Other
treatment efficacy
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Outcome_Physical
ulcer healing rate
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Outcome_Physical
Vital signs
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Outcome_Other
blood/ urine analysis
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Outcome_Other
endoscopic ulcer healing rate
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Outcome_Physical
Healing rate
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Outcome_Physical
development of symptoms
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Outcome_Pain
number of episodes of ulcer-related pain
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Outcome_Physical
total ulcerated surface area
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Outcome_Other
tolerance
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Outcome_Adverse-effects
side effects
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Participant_Condition
110 duodenal ulcer patients