A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to evaluate the acid-inhibitory and dose-response efficacy of TAK-438 (20 mg, 40 mg) in patients with PPI-resistant erosive esophagitis.

Condition or disease	Intervention/treatment	Phase
Erosive Esophagitis	Drug: TAK-438	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19 participants
Primary Purpose:	Treatment
Study Start Date :	July 2012
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: TAK-438 20 mg/day	Drug: TAK-438
Experimental: TAK-438 40 mg/day	Drug: TAK-438

Outcome Measures

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Primary Outcome Measures :

1. Time-course of changes in 24-hour gastroesophageal pH [ Time Frame: Week 8 ]
   Gastric and esophageal pH4 HTR (pH 4 Holding Time Ratio) will be calculated based on 24-hour gastroesophageal pH monitoring.

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase.
2. Outpatient (in principle)
3. At the endoscopy scheduled for the Observation Phase (Visit 2), the participant must have endoscopically confirmed reflux esophagitis of Grade A to D, as defined by the LA classification grading system, which remains insufficiently controlled with standard-dose or higher-than-standard-dose PPI therapy.
4. The participant showed good compliance to the study medication in the Observation Phase (compliance rate 80% or more).

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) at the start of the Observation Phase (Visit 1) or at endoscopy during the Observation Phase (Visit 2) . 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.

Contacts and Locations

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Locations

Japan
Gifu-shi, Gifu, Japan
Sapporo-shi, Hokkaido, Japan
Hitachi-shi, Ibaraki, Japan
Kochi-shi, Kochi, Japan
Sendai-shi, Miyagi, Japan
Osaka-shi, Osaka, Japan
Saga-shi, Saga, Japan
Izumo-shi, Shimane, Japan
Hamamatsu-shi, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan

Sponsors and Collaborators

Takeda

Investigators

Study Director:	Medical Director	Takeda

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Takeda
ClinicalTrials.gov Identifier:	NCT01630746 History of Changes
Other Study ID Numbers:	TAK-438/OCT-002; JapicCTI-121882 ( Registry Identifier: JapicCTI ); U1111-1130-9074 ( Registry Identifier: WHO )
First Posted:	June 28, 2012
Last Update Posted:	February 10, 2014
Last Verified:	February 2014

Additional relevant MeSH terms:

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases	Gastroenteritis; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action