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
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ClinicalTrials.gov Identifier: NCT01630746 |
Recruitment Status :
Completed
First Posted : June 28, 2012
Last Update Posted : February 10, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erosive Esophagitis | Drug: TAK-438 | Phase 3 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: TAK-438 20 mg/day |
Drug: TAK-438 |
Experimental: TAK-438 40 mg/day |
Drug: TAK-438 |
- 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase.
- Outpatient (in principle)
- 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.
- The participant showed good compliance to the study medication in the Observation Phase (compliance rate 80% or more).
Exclusion Criteria:
- 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.
- 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)
- 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.
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630746
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 |
Study Director: | Medical Director | Takeda |
Responsible Party: | Takeda |
ClinicalTrials.gov Identifier: | NCT01630746 |
Other Study ID Numbers: |
TAK-438/OCT-002 JapicCTI-121882 ( Registry Identifier: JapicCTI ) U1111-1130-9074 ( Registry Identifier: WHO ) |
First Posted: | June 28, 2012 Key Record Dates |
Last Update Posted: | February 10, 2014 |
Last Verified: | February 2014 |
Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |