A Phase 3, Double-Blind Study of TAK-438 (10 mg or 20 mg) in the Maintenance Treatment of Erosive Esophagitis

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) compared to AG-1749 (15 mg Once-Daily) in a 24-week Maintenance Treatment in Patients with Healed Erosive Esophagitis (EE).

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221621

Enrollment

600

Registered

2011-10-17

Start date

2011-10-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive esophagitis

Interventions

investigational material(s) Generic name etc : TAK-438 INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.At Visit H-1 (start of the treatment period), the participants must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 15% or more of the total participants. 2.Outpatients (including inpatient for examination) 3.Participants must have successfully completed the treatment period and have endoscopically healed EE at Week 2, 4, or 8 in the treatment period.

Exclusion criteria

Exclusion criteria: 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 H-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 disorder

Design outcomes

Primary

Measure	Time frame
Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment Endoscopic reccurence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D as defined by the Los Angeles (LA) Classification Grading System.	—

Secondary

Measure	Time frame
Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026