None listed
Conditions
Interventions
This group will be treated with TAK-390 60 mg PO QD for 8 weeks.
Group name:GROUP III Type of group
This group will be treated with Lansoprazole 30 mg PO QD for 8 weeks.
Sponsors
TAP PHARMACEUTICAL PRODUCTS INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Before any specific procedure of the study is performed, the patient will voluntarily sign an Informed Consent Form (ICF). 2. Male or female patients with at least 18 years of age. 3. All patients must have a negative serum pregnancy test in the Selection and a negative urine pregnancy test on Day -1 and be using and agree to continue using a double-barrier method of contraception. 4. Patients should have endoscopically confirmed ES.
Exclusion criteria
Exclusion criteria: 1. The patients seropositive for H. pylori. However, patients who are seropositive and have received therapeutically approved eradication treatment within the last 6 months will have the right to participate. 2. Use of proton pump inhibitors (PPIs) prescribed or not prescribed during the 14 days before the selection endoscopy and throughout the study. 3. Use of histamine (H2) antagonist receptors or sucralfate prescribed or not prescribed during the 7 days before the endoscopy of Selection and throughout the study. 4. Use of antacids during the Selection and Treatment Periods. 5. Patients who use medications with important anticholinergic effects. 6. Patients who can not stop using the following medications: a) Misoprostol. b) Prokinetics. 7. Need continuous anticoagulant treatment. 8. Use of any investigational medication within 30 days of the Selection. 9. Cancer within the previous 3 years. 10. Any condition that may require surgery during the course of the study. 11. Barrett´s esophagus and / or dysplastic changes endoscopically confirmed in the esophagus. 12. Patients with a history of dilatation due to esophageal stenosis, different from Schatzki´s ring. 13. Patients with active gastric or duodenal ulcers within 4 weeks of the first dose of the study medication. 14. Concomitant diseases that affect the esophagus, history of treatment with radiation or cryotherapy in the esophagus, caustic or physicochemical trauma such as sclerotherapy for the esophagus. 15. Evidence of uncontrolled systemic disease. 16. Patients with abnormal laboratory values ​​that suggest a clinically important underlying disease or condition. 17. Patient known as a carrier of acquired immunodeficiency syndrome (AIDS). 18. Current or previous evidence of Zollinger-Ellison syndrome or another hypersecretory condition. 19. History of gastric, duodenal or esophageal surgery except simple suture of an ulcer. 20. Acute upper gastrointestinal bleeding within 4 weeks of selection endoscopy. 21. Patients who have received blood products within 3 months prior to the first dose of the study medication. 22. Known hypersensitivity to any PPI, any component of TAK-390MR, or Gelusil / antacid. 23. Women who are pregnant or breastfeeding. 24. History of alcohol abuse or illegal use of drugs or drug addiction in the 12 months prior to the Selection. 25. Patients who can not meet the requirements of the study or are not suitable for some reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Standard endoscopy. Measure:Percentage of patients with complete cure of the EE at 8 weeks. Timepoints:Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Standard endoscopy. Measure:Secondary Efficacy: 1) The percentage of patients who have a complete cure of the EE at 4 weeks as assessed by endoscopy. 2) The percentage of patients with initial grade C or D combined EE who have a complete cure of the EE at 8 weeks as assessed by endoscopy. Timepoints:Before starting the treatment and weeks 4 and 8. ; Outcome name:Standard endoscopy. Electronic diary of the patient. PAGI-QOL quality of life index. Measure:Other criteria of effectiveness: 1) Percentage of patients who have a complete cure of the EE in Week 4 or Week 8. 2) Average percentage of days without day or night acidity at 8 weeks. 3) Average percentage of days without daytime acidity at 8 weeks. 4) Average percentage of days without nocturnal acidity at 8 weeks. 5) Average severity during daytime and nightime acidity at 8 weeks 6) Average daily acidity severity at 8 weeks. 7) Average severity of nocturnal acidity at 8 weeks. 8) Percentage of patients without diurnal and nocturnal acidity during the first 3 days of treatment. 9) Time to sustained resolution of acidity, defined as 7 consecutive days without daytime and nocturnal acidity. 10) Average percentage of days without rescue medication at 8 weeks. 11) Average severity of GERD symptoms in Week 4 or Week 8. 12) Average change from the initial in the QOL measurements in Week 4 and Week 8. Timepoints:Standard endoscopy, quality of life index PAGI-QOL: Before starting treatment and weeks 4 and 8. Electronic diary of the patient: Every day during the 8 weeks of treatment and during the follow-up. ; Outcome name:Clinical evaluation of adverse events according to the Medical Dictionary for Regulatory Dependencies (MedDRA). Laboratory evaluations: Blood chemistry panels, serum chemistry, urine test. Serum gastrin levels. Physical examination and vital signs. Measure:Safety of the treatment. Timepoints:Clinical evaluation of adverse events: | — |
Countries
Australia, Bulgaria, Canada, Colombia, Czech Republic, Germany, India, Latovia, Lithuania, New Zealand, Poland, Russian Federation, Slovakia, South Africa, United States
Outcome results
None listed