A Phase 3, Long-Term Study of TAK-438 (10 and 20 mg) in the Maintenance Treatment of Healed Erosive Esophagitis
- Conditions
- Erosive esophagitis
- Registration Number
- JPRN-jRCT2080221575
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 300
1. Participants must have successfully completed the preceding phase 3 double-blind study (TAK-438/CCT-002: preceding study) and have endoscopically healed EE at Week 2, 4 or 8 in the preceding study.*
*Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System.
2. Outpatient (including inpatient for examination)
1. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus 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 who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit M-1 (initiation of study drug administration). However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Treatment-emergent Adverse Events<br>Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit.<br><br>Timeframe:52 weeks
- Secondary Outcome Measures
Name Time Method aboratory Values, Electrocardiograms, Vital Signs, Serum Gastrin, Pepsinogen I and II, and Endoscopically confirmed recurrence rate of Erosive Esophagitis <br>Timeframe:52 weeks