- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630746
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
February 7, 2014 updated by: Takeda
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gifu
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Gifu-shi, Gifu, Japan
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Hokkaido
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Sapporo-shi, Hokkaido, Japan
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Ibaraki
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Hitachi-shi, Ibaraki, Japan
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Kochi
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Kochi-shi, Kochi, Japan
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Miyagi
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Sendai-shi, Miyagi, Japan
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Osaka
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Osaka-shi, Osaka, Japan
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Saga
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Saga-shi, Saga, Japan
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Shimane
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Izumo-shi, Shimane, Japan
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Shizuoka
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Hamamatsu-shi, Shizuoka, Japan
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Tokyo
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Bunkyo-ku, Tokyo, Japan
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Mitaka-shi, Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TAK-438 20 mg/day
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Experimental: TAK-438 40 mg/day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-course of changes in 24-hour gastroesophageal pH
Time Frame: Week 8
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Gastric and esophageal pH4 HTR (pH 4 Holding Time Ratio) will be calculated based on 24-hour gastroesophageal pH monitoring.
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Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
June 26, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 28, 2012
Study Record Updates
Last Update Posted (Estimate)
February 10, 2014
Last Update Submitted That Met QC Criteria
February 7, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-438/OCT-002
- JapicCTI-121882 (Registry Identifier: JapicCTI)
- U1111-1130-9074 (Registry Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erosive Esophagitis
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Onconic Therapeutics Inc.RecruitingErosive EsophagitisKorea, Republic of
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AstraZenecaLaboratory Corporation of America; Medidata Solutions; IQVIA RDS Inc.; Calyx; Thermo... and other collaboratorsRecruitingErosive EsophagitisUnited States, Italy, Belgium, Vietnam, Spain, Portugal, Russian Federation, Argentina, Greece, Australia, Lithuania
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Konkuk University Medical CenterDaewoong Pharmaceutical Co. LTD.RecruitingErosive EsophagitisKorea, Republic of
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Cinclus Pharma AGParexelCompletedErosive EsophagitisPoland, Bulgaria, Serbia, Georgia, United States, Czechia, Hungary, Ukraine
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Boryung Pharmaceutical Co., LtdCompleted
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HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
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HK inno.N CorporationCompletedErosive EsophagitisKorea, Republic of
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TakedaCompletedErosive EsophagitisJapan
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Braintree LaboratoriesRecruitingErosive EsophagitisUnited States
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Phathom Pharmaceuticals, Inc.CompletedErosive EsophagitisUnited States, Poland, Bulgaria, United Kingdom, Czechia, Hungary
Clinical Trials on TAK-438
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TakedaCompletedJapanese Healthy Adult MaleJapan
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TakedaCompleted
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TakedaCompletedGastroesophageal Reflux Disease (GERD) | Erosive Esophagitis(EE)United Kingdom
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TakedaCompleted
-
TakedaCompletedErosive EsophagitisJapan
-
TakedaCompletedAscending Single Dose Study
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TakedaCompletedNon-erosive Gastroesophageal Reflux DiseaseJapan
-
TakedaCompletedNon-erosive Gastroesophageal Reflux DiseaseJapan
-
TakedaCompletedGastric Ulcer, Duodenal Ulcer, and Reflux EsophagitisJapan
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TakedaCompleted