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軽度逆流性食道炎におけるラフチジンの検証試験 - ファモチジンとの二重盲検対照試験 -

基本情報

NCT ID
NCT00229424
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
325
治験依頼者名
Taiho Pharmaceutical Co., Ltd.

概要

The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.

対象疾患

Gastroesophageal Reflux

介入

Lafutidine(DRUG)
Famotidine(DRUG)
Placebo(OTHER)

依頼者(Sponsor)

実施施設 (1)

東北大学病院

1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan