| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To assess the efficacy of TAK 390MR (60 mg QD and 90 mg QD) compared to lansoprazole (30 mg QD) in healing EE over 8 weeks in subjects with endoscopically proven EE.
To assess the safety of TAK-390MR (60 mg QD and 90 mg QD) compared to Lansoprazole (30 mg QD) in subjects with endoscopically proven EE
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| E.2.2 | Secondary objectives of the trial |
To assess the efficacy of TAK-390MR (60 mg QD and 90 mg QD) compared to lansoprazole (30 mg QD) in healing EE over 4 weeks in subjects with endoscopically proven EE.
To assess the efficacy of Tak-390MR (60 mg QD and 90 mg QD) compared to lansoprazole (30 mg QD) in healing EE over 8 weeks in subjects with endoscopically proven moderate to severe EE.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
1. Prior to any study-specific procedures being performed, the subject voluntarily signs an Informed Consent Form (ICF)/and any privacy statement/authorization form required by the region in which the subject is participating, after having its contents fully explained and all questions answered. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) must approve the ICFs.
2. Male or female subjects at least 18 years of age (and of legal age of consent).
3. All female subjects must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 and are using, and agree to continued use of, a double barrier method of birth control. Oral, injectable or patch contraceptives may be used as one method if the subject has been taking them for greater than three months duration at the Screening Visit. Subjects who have had a bilateral tubal ligation, hysterectomy or are post-menopausal (the absence of menses for 1-2 years with a Follicle-Stimulating Hormone [FSH] level 40 IU/L or absence of menses for > 2 years) are not required to use birth control.
4. Subject must have endoscopically confirmed EE as defined by the Los Angeles (LA) Classification Grading System (A-D).
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| E.4 | Principal exclusion criteria |
1. Subject tests sero-positive for H pylori. However, subjects who are sero-positive and have received therapeutically approved eradication therapy within the past 6 months will be allowed to participate. Subjects who are sero-positive for H pylori and are treated with a documented therapeutically approved eradication therapy (outside of the study) will be allowed to screen again, provided they re-sign the Informed Consent/and any privacy statement/authorization form required by the region in which the subject is participating and begin screening procedures a minimum of 14 days post completion of eradication therapy.
2. Use of prescription or non-prescription proton pump inhibitors (PPIs) during the 14 days prior to the Screening endoscopy and throughout the study.
3. Use of prescription or non-prescription histamine (H2) receptor antagonists or sucralfate during the 7 days prior to the Screening endoscopy and throughout the study.
4. Use of antacids [except for study supplied Gelusil® (U.S. sites), or a similar equivalent approved antacid (ex U.S. sites)] during the Screening and Treatment Periods.
5. Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for the 4 weeks prior to dosing and throughout the study.
6. Subjects who cannot discontinue the use of the following medications prior to the first dose of study drug and throughout the study: misoprostol prokinetics
7. Need for continuous anticoagulant therapy.
8. Use of any investigational drug(s) within 30 days of Screening.
9. Cancer (except basal cell carcinoma of the skin) within 3 years prior to Screening.
10 Any condition that may require inpatient surgery during the course of the study.
11. Endoscopic Barrett’s esophagus and/or definite dysplastic changes in the esophagus. If any suspicious Barrett’s esophagus is seen during screening and the principal investigator is confident that the subject will be confirmed with Barrett’s, the subject may be automatically excluded. Otherwise, any suspicious Barrett’s esophagus seen during screening endoscopy will be biopsied and sent to a local pathology laboratory. Subjects may be randomized; however, the subject must be discontinued if the Screening biopsy is found to confirm Barrett’s and/or to have definite dysplastic changes. If the subject is discontinued, Final Visit procedures must be performed, with the exception of the endoscopy. Subjects with indeterminate dysplasia due to severe inflammation may be enrolled and rebiopsied at the next endoscopy.
12. Subjects with a history of dilatation of esophageal strictures, other than a Schatzki’s ring (a ring of mucosal tissue near the lower esophageal sphincter).
13. Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose of study drug.
14. Co-existing diseases affecting the esophagus (eg, esophageal varices, scleroderma, viral, fungal infection or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
15. Evidence of uncontrolled systemic disease.
16. Subject has abnormal laboratory values that suggest a clinically significant underlying disease or condition that may prevent the subject from entering the study or subject with the following lab abnormalities: Creatinine >1.5 mg/dL, Alanine Aminotransferase (ALT) and /or Aspartate Aminotransferase (AST) >2.5X the upper limits of normal, or Bilirubin >2.0 mg/dl with AST/ALT elevated above normal values.
17. Subject known to have acquired immunodeficiency syndrome (AIDS).
18. Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
19. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
20. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy.
21. Subject has received blood products within 3 months prior to the first dose of study drug.
22. Known hypersensitivity to any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of TAK-390MR, or Gelusil/antacid.
23. Females who are pregnant or lactating.
24. History of alcohol abuse [>21 units (1 unit = 12 oz beer, 1.5 oz hard liquor, or 5 oz wine) per week] or illegal drug use or drug addiction in the 12 months prior to Screening.
25. Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The percentage of subjects who have complete healing of EE over 8 weeks as assessed by endoscopy. |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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