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

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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

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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