Clinical Trials List
2015-08-17 - 2018-02-28
Phase III
Terminated12
ICD-10K20.9
Esophagitis, unspecified
ICD-10K21.0
Gastro-esophageal reflux disease with esophagitis
A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Takeda Development Center Asia, Pte. Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Wei-Lun Chang Digestive System Department
- Hsin-Yu Kuo Digestive System Department
- 吳忠泰 Division of General Internal Medicine
- 鄭興 Digestive System Department
- Hsiu-Chi Cheng Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳介章 Digestive System Department
- 陳美志 Digestive System Department
- JYH-MING LIOU Digestive System Department
- 曾屏輝 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- Jiing-Chyuan Luo Digestive System Department
- 陳炳憲 Digestive System Department
- 王彥博 Digestive System Department
The Actual Total Number of Participants Enrolled
2 Terminated
Audit
None
Co-Principal Investigator
- Huang-Ming Hu Digestive System Department
- I-CHEN WU Digestive System Department
- Chien-Yu Lu Digestive System Department
- Chao-Hung Kuo Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 余承儒 Digestive System Department
- Jen-Wei Chou Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳季宏 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Taiwan National PI
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 許振銘 Digestive System Department
- Ming-Yao Su Digestive System Department
- 何玉彬 Digestive System Department
- 林淳榮 Digestive System Department
The Actual Total Number of Participants Enrolled
16 Terminated
Audit
None
Chairman/Global PI
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- Wei-Yu Kao Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The secondary efficacy endpoint for this study is the rate of recurrence of erosive esophagitis during the 12 weeks of treatment in the Maintenance Phase.
Other efficacy endpoints include subjective symptoms of erosive esophagitis (heartburn and regurgitation) and Health-Related Quality of Life measures.
Safety:
The safety endpoints of this study include adverse events, laboratory test values, ECG, vital signs, serum gastrin and pepsinogen I/II values.
Inclution Criteria
2. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. The subject has been confirmed on endoscopy to have had erosive esophagitis (LA
classification grades A to D) within 84 days of Day 1. At least 15% (90 subjects) of LA grades C/D subjects should be enrolled in this study to ensure sufficient enrollment of subjects with severe disease and to perform subgroup analysis.
Note: The recruitment goal is to enroll subjects so that those with a history of LA classification grade C/D will account for more than 15% of all subjects (90/600) and those with a history of grade A/B will not be recruited further when they account for more than 85% (510/600) of all subjects.
4. The subject has undergone PPI treatment if he/she is not rolled over from TAK-438_303 study.PPI treatment is defined as the treatment with at least 2 weeks on a registered dose of a PPI combined with an endoscopy within 1 week of randomization confirming healing of the erosive esophagitis.
5. The subject has been confirmed on endoscopy to have healing of erosive esophagitis. This endoscopy, if not part of the TAK-438_303 study, must have been within the last 1 week prior to randomization, otherwise the endoscopy must be repeated to confirm healing before randomization in the TAK-438_305 study.
6. The subject is aged 18 years old or older (or the local age of consent if that is older), male or female, at the time of signing an informed consent, and is being treated on an outpatient basis for erosive esophagitis, including those temporarily admitted for examination.
7. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use routinely adequate contraception* from signing of informed consent throughout the duration of the study and for 4 weeks after last dose of study medication.
*Definitions and acceptable methods of contraception are defined in Section 9.1.9 Contraception and Pregnancy Avoidance Procedure and reporting responsibilities are defined in Section 9.1.10 Pregnancy.
Exclusion Criteria
within 84 days prior to screening phase.
2. The subject has received TAK-438 in a previous clinical study (other than study
TAK-438_303) or as a therapeutic agent.
3. The subject is an immediate family member, study site employee, or is in a dependent
relationship with a study site employee who is involved in conduct of this study (eg, spouse,parent, child, sibling) or may consent under duress.
4. The subject has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
5. The subject has a history or clinical manifestations of significant CNS, cardiovascular,pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease.
6. The subject has a history of hypersensitivity or allergies to TAK-438 or to proton pump inhibitors (PPIs) including any associated excipients*.
* D-mannitol, crystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, yellow iron sesquioxide and iron sesquioxide.
7. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the start the screening phase.
8. The subject is required to take excluded medications listed in Section 7.3.
9. If female, the subject is pregnant or lactating or intending to become pregnant before, during,or within 1 month after participating in this study; or intending to donate ova during such time period.
10. The subject has participated in another clinical study (other than study TAK-438_303) within the past 30 days from Visit 1.
11. The subject has co-morbidities that could affect the esophagus (eosinophilic esophagitis,esophageal varices, scleroderma, viral or fungal infection, esophageal strictures), a history of radiotherapy or cryotherapy for the esophagus; those with corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki’s ring or Barrett’s esophagus).
12. The subject has a history of surgical procedures that may affect the esophagus (eg,
fundoplication and mechanical dilatation for esophageal strictures excluding Schatzki’s ring) or a history of gastric or duodenal surgery excluding endoscopic removal of benign polyps.
13. The subject developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Phase (Visit 1) (with the possible inclusion of those with gastric or duodenal erosion). The subjects requiring NSAIDs or aspirin treatment along with the concomitant PPI therapy to prevent GI bleeding should not be enrolled.
14. The subject has Zollinger-Ellison syndrome or gastric acid hypersecretion or a history of gastric acid hypersecretion.
15. The subject is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
16. The subject has a history of malignancy or was treated for malignancy within 5 years before the start of the Screening Phase (visit 1) (the subject may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
17. The subject has acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers (HBs-antigen or HCV-antibody-positive) (the subject may be included in the study if he/she is HCV-antigen or HCV-RNA-negative).
18. Laboratory tests performed on visit 1 revealed any of the following abnormalities in the subject:
a) Creatinine levels: > 2 mg/dL (>177 μmol/L)
b) ALT, AST or total bilirubin levels: > the upper limit of normal (ULN).
The Estimated Number of Participants
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Taiwan
80 participants
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Global
693 participants
