A Phase 3 Double-Blind Study of TAK-438 (10 mg or 20 mg) in the Treatment of Non-Erosive Gastroesophageal Reflux Disease
- Conditions
- on-erosive gastroesophageal reflux disease
- Registration Number
- JPRN-jRCT2080221622
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 840
1.Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).
2.Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of the pre-observation period (VISIT 1).
3.Participants with severity of moderate or higher for acid reflux symptoms (heartburn or acid reflux) in the 3 weeks before initiation of the pre-observation period (VISIT 1)
4.Outpatients (hospitalization for testing possible)
1.Participants with an esophagus-related complication [Barrett's esophagus (3 cm or more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, esophageal stenosis, etc.], or a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.).
However, participants with Barrett's esophagus (less than 3 cm, SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) are allowed to be included.
2.Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
3.Participants with acute upper gastrointestinal bleeding, gastric ulcers (mucosal defects associated with white coating) or duodenal ulcers (mucosal defects associated with white coating) within 30 days before initiation of the pre-observation period (VISIT 1).
However, participants with gastric or duodenal erosions are allowed to be included.
4.Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication
5.Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
6.Participants with a previous or current history of chest pain due to heart disease or with chest pains suspected of being caused by heart disease within one year before initiation of the pre-observation period (VISIT 1)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Heartburn symptoms in 4 weeks of treatment <br>Heartburn symptoms will be collected by participant diaries.<br>Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn are evaluation parameters.
- Secondary Outcome Measures
Name Time Method Primary endpoint stratified by Week 2 improvement<br>Primary endpoint stratified by endoscopic findings (grade N or M)<br>Primary endpoint stratified by Week 2 improvement and endoscopic findings (grade N or M)