A Phase 3, Clinical Pharmacology Study of TAK-438 (20 mg, 40 mg) in Patients with PPI-Resistant Erosive Esophagitis

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Dose-Response Relationships of Acid-Inhibitory Effect and Efficacy of TAK-438 (20 mg, 40 mg) in Patients with PPI-Resistant Erosive Esophagitis.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221838

Enrollment

Registered

2012-06-25

Start date

2012-06-25

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.The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase. 2.Outpatient (in principle) 3.At the endoscopy scheduled for the Observation Phase (Visit 2), the participant must have endoscopically confirmed reflux esophagitis of Grade A to D, as defined by the LA classification grading system, which remains insufficiently controlled with standard-dose or higher-than-standard-dose PPI therapy. 4.The participant showed good compliance to the study medication in the Observation Phase (compliance rate 80% or more).

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) at the start of the Observation Phase (Visit 1) or at endoscopy during the Observation Phase (Visit 2). 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.

Design outcomes

Primary

Measure	Time frame
Time-course of changes in 24-hour gastroesophageal pH. Timeframe:Week 8 Gastric and esophageal pH4 HTR (pH 4 Holding Time Ratio) will be calculated based on 24-hour gastroesophageal pH monitoring.	—

Secondary

Measure	Time frame
Endoscopic healing rate at Week 8 of erosive esophagitis Timeframe:Week 8	—

Outcome results

None listed

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