Scholarlink

Background <p>Currently, there are no established treatments for esophagogastric junction outflow obstruction (EGJOO). In this study, we evaluated the efficacy and safety of acotiamide for EGJOO by targeting impaired lower esophageal sphincter (LES) function.</p> Methods <p>This investigator-initiated, multicenter, randomized, double-blind, placebo-controlled phase II trial enrolled 35 patients with EGJOO between December 2021 and December 2023. Patients were randomized to receive either placebo (<i>n</i> = 11) or acotiamide (300&#xa0;mg/day, <i>n</i> = 12; 600&#xa0;mg/day, <i>n</i> = 12) for 4&#xa0;weeks (placebo-controlled period). Subsequently, all patients received 600&#xa0;mg/day acotiamide for an additional 4&#xa0;weeks (open-label period).</p> Results <p>As a primary endpoint, during the placebo-controlled period, the improvement rate of food-sticking symptoms in the chest was 12.5% and 0.0% in the acotiamide and placebo groups, respectively (<i>p</i> = 0.3092). In terms of secondary endpoints, the integrated relaxation pressure (IRP) normalization rate was significantly higher in the acotiamide group (41.7%) than in the placebo group (0.0%) (<i>p</i> = 0.0107). No other secondary endpoints showed significant differences between the groups. Regarding the exploratory endpoints, during the open-label period, among the 24 patients treated with ≥ 300&#xa0;mg/day of acotiamide for 8&#xa0;weeks, the improvement rate of food-sticking symptoms in the chest increased to 37.5%, and the IRP normalization rate rose to 54.2%.</p> Conclusions <p>Acotiamide is effective in normalizing impaired LES relaxation in patients with EGJOO and may improve food-sticking symptoms in the chest.</p> Clinical trial registration <p>Japan Registry of Clinical Trials (<a href="https://jrct.mhlw.go.jp/en-top">https://jrct.mhlw.go.jp/en-top</a>); registration number jRCT2071210072.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Efficacy and safety of acotiamide in esophagogastric junction outflow obstruction: a placebo-controlled phase II trial

  • 期刊论文

  • 发表日期：

    2026年2月16日

查看全文
  • Eikichi Ihara,
  • Haruei Ogino,
  • Mitsuru Esaki,
  • Noriaki Manabe,
  • Noriyuki Kawami,
  • Katsuhiko Iwakiri,
  • Junichi Akiyama,
  • Shiko Kuribayashi,
  • Toshio Uraoka,
  • Hirotaka Tsuru,
  • Masafumi Wada,
  • Yoshitaka Hata,
  • Kazumasa Muta,
  • Xiaopeng Bai,
  • Yosuke Minoda,
  • Yoshimasa Tanaka,
  • Takatoshi Chinen,
  • Hiroko Watanabe,
  • Kayo Toyosaki,
  • Akihiro Fukuda,
  • Maya Suzuki,
  • Junji Kishimoto,
  • Yoshihiro Ogawa

摘要

Background

Currently, there are no established treatments for esophagogastric junction outflow obstruction (EGJOO). In this study, we evaluated the efficacy and safety of acotiamide for EGJOO by targeting impaired lower esophageal sphincter (LES) function.

Methods

This investigator-initiated, multicenter, randomized, double-blind, placebo-controlled phase II trial enrolled 35 patients with EGJOO between December 2021 and December 2023. Patients were randomized to receive either placebo (n = 11) or acotiamide (300 mg/day, n = 12; 600 mg/day, n = 12) for 4 weeks (placebo-controlled period). Subsequently, all patients received 600 mg/day acotiamide for an additional 4 weeks (open-label period).

Results

As a primary endpoint, during the placebo-controlled period, the improvement rate of food-sticking symptoms in the chest was 12.5% and 0.0% in the acotiamide and placebo groups, respectively (p = 0.3092). In terms of secondary endpoints, the integrated relaxation pressure (IRP) normalization rate was significantly higher in the acotiamide group (41.7%) than in the placebo group (0.0%) (p = 0.0107). No other secondary endpoints showed significant differences between the groups. Regarding the exploratory endpoints, during the open-label period, among the 24 patients treated with ≥ 300 mg/day of acotiamide for 8 weeks, the improvement rate of food-sticking symptoms in the chest increased to 37.5%, and the IRP normalization rate rose to 54.2%.

Conclusions

Acotiamide is effective in normalizing impaired LES relaxation in patients with EGJOO and may improve food-sticking symptoms in the chest.

Clinical trial registration

Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp/en-top); registration number jRCT2071210072.