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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
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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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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, Older Adult)
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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Information from the National Library of Medicine

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


Locations
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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
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Study Director: Medical Director Takeda
More Information
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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
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis