Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis

Takeda

Status and phase: Completed; Phase 3

Conditions: Erosive Esophagitis

Treatments: Drug: TAK-438

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452776

U1111-1123-9677 (Registry Identifier)

JapicCTI-111615 (Registry Identifier)

TAK-438/OCT-001

Details and patient eligibility

About

The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.

Enrollment: 305 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

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 disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

305 participants in 2 patient groups

TAK-438 10 mg QD

Experimental group

Treatment:

Drug: TAK-438

Drug: TAK-438

TAK-438 20 mg QD

Experimental group

Treatment:

Drug: TAK-438

Drug: TAK-438