Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis

Takeda

Status and phase: Completed; Phase 3

Conditions: Erosive Esophagitis

Treatments: Drug: TAK-438; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01459367

JapicCTI-111662 (Registry Identifier)

U1111-1125-1054 (Registry Identifier)

TAK-438/CCT-003

Details and patient eligibility

About

The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.

Enrollment: 607 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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. Endoscopically healed EE is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the LA classification grading system.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

607 participants in 3 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

Lansoprazole 15 mg QD

Active Comparator group

Treatment:

Drug: Lansoprazole