A Phase 3, Long-Term Study of TAK-438 (10 and 20 mg) in the Maintenance Treatment of Healed Erosive Esophagitis

A Phase 3, Randomized, Single-Blind, Multicenter Study to evaluate the Safety of TAK-438 (10 and 20 mg once-daily) in a 52-week maintenance treatment in patients with Healed Erosive Esophagitis (EE).

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221575

Enrollment

300

Registered

2011-09-07

Start date

2011-09-07

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. 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)

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 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.

Design outcomes

Primary

Measure	Time frame
Incidence of Treatment-emergent Adverse Events 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. Timeframe:52 weeks	—

Secondary

Measure	Time frame
Laboratory Values, Electrocardiograms, Vital Signs, Serum Gastrin, Pepsinogen I and II, and Endoscopically confirmed recurrence rate of Erosive Esophagitis Timeframe:52 weeks	—

Outcome results

None listed

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