DA-9601 for erosive gastritis: results of a double-blind placebo-controlled phase III clinical trial.
World J Gastroenterol
; 10(16): 2379-82, 2004 Aug 15.
Article
em En
| MEDLINE
| ID: mdl-15285023
ABSTRACT
AIM:
To determine the efficacy and safety of DA-9601 on erosive gastritis versus cetraxate as a standard drug by gastrointestinal endoscopy.METHODS:
Five hundred and twelve patients with erosive gastritis were divided into three groups. The groups received 180 mg or 360 mg of DA-9601, or 600 mg of cetraxate (Neuer) t.i.d. for 2 wk, respectively. Endoscopic observations were performed before and 2 wk after the treatment, and the cure and improvement rates were investigated.RESULTS:
Of the 512 intention-to-treat (ITT) population, 457 patients comprised the per protocol (PP) analysis. Endoscopic cure rate was significantly higher in the DA-9601 group than in the cetraxate group in both the PP (56%, 58% vs 36%; DA-9601 180 mg, 360 mg and cetraxate, respectively) and ITT (52%, 51% vs 35%) populations. Two DA-9601 groups (180 and 360 mg) had significantly higher endoscopic improvement rates than the cetraxate group in both the PP (67%, 65% vs 46%) and ITT (63%, 58% vs 45%) populations. The percentage of symptom relief over the 2 wk was found not significantly different between groups. During the study, both DA-9601 and cetraxate produced no treatment-associated adverse events.CONCLUSION:
From these results, it appears that DA-9601 has excellent efficacy on erosive gastritis. This study also confirms the safety profile of DA-9601.
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Ácido Tranexâmico
/
Extratos Vegetais
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Gastrite
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Fitoterapia
Tipo de estudo:
Clinical_trials
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Guideline
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2004
Tipo de documento:
Article