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

Phase 3

Completed

• Conditions: Erosive Esophagitis
• Interventions: Drug: TAK-438

• Registration Number: NCT01452776
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-17
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-02
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-438 10 mg QD	TAK-438	-
TAK-438 20 mg QD	TAK-438	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events	52 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Laboratory Values	Baseline and Week 52
Change from Baseline in Electrocardiograms	Baseline and Week 52
Change from Baseline in Vital Signs	Baseline and Week 52
Change from Baseline in Serum Gastrin	Baseline and Week 52
Change from Baseline in Pepsinogen I and II	Baseline and Week 52
Endoscopically confirmed recurrence rate of Erosive Esophagitis	52 Weeks