Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
- Conditions
- K20-K20 OesophagitisOesophagitis
- Registration Number
- PER-047-06
- Lead Sponsor
- TAP PHARMACEUTICAL PRODUCTS INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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 endoscopic confirmed erosive esophagitis (EE) as defined by the Classification System (A-D) of Los Angeles (LA).
1. The seropositive patients for H, pylori.
2. Use of proton pump inhibitors (PPIs) prescribed or not prescribed during the selection and throughout the study.
3. Use of histamine (H2) antagonist receptors or sucralfate prescribed or not prescribed during the selection and throughout the study.
4. Chronic use (> 12 doses per month) of non-steroidal anti-inflammatory drugs (NSAIDs) including.
5. Use of antacids [except for the Gelusil® supplied by the study (for centers in the USA) or a similar approved equivalent antacid (for centers outside of the US) during the Selection and Treatment Periods.
6. Patients who use medications with significant anticholinergic effects that can not be maintained at a stable dose during the 4 weeks prior to administration and throughout the study.
7. Patients who can not stop using the following medications before the first dose of the study medication and throughout the study: a) Misoprostol. b) Prokinetic
8. Need continuous anticoagulant treatment.
9. Use of any investigational medication within 30 days of the Selection.
10. Cancer within 3 years prior to the Selection.
11. Any condition that may require surgery during the course of the study.
12. Barrett´s esophagus and / or dysplastic changes endoscopically confirmed in the esophagus.
13. Patients with a history of dilatation due to esophageal stenosis, different from Schatzki´s ring.
14. Patients with active gastric or duodenal ulcers within 4 weeks of the first dose of the study medication.
15. 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.
16. Evidence of uncontrolled systemic disease.
17. Patients with abnormal laboratory values that suggest a clinically important underlying disease or condition that may prevent the patient from entering the study or the patient have the following laboratory abnormalities: Creatinine> 1.5 mg / dL, Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST)> 2.5X of the upper limits of normal, or Bilirubin> 2.0 mg / dL with elevated AST / ALT above normal values.
18. Patient known as a carrier of acquired immunodeficiency syndrome (AIDS).
19. Current or previous evidence of Zollinger-Ellison syndrome or another hypersecretory condition.
20. History of gastric, duodenal or esophageal surgery except simple suture of an ulcer.
21. Acute upper gastrointestinal bleeding within 4 weeks of selection endoscopy.
22. Patients who have received blood products within 3 months prior to the first dose of the study medication.
23. Known hypersensitivity to any PPI, any component of TAK-390MR, or Gelusil / antacid.
24. Women who are pregnant or breastfeeding.
25. History of alcohol abuse or illegal use of drugs or drug addiction in the 12 months prior to the Selection.
26. Patients who can not meet the requirements of the study or are not suitable for some reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Endoscopy for the documentation of the absence or presence of erosive esophagitis (EE) and its classification according to the criteria of Los Angeles (A-D).<br>Measure:Percentage of patients who have a complete cure of EE.<br>Timepoints:Week 8.<br>;<br>Outcome name:Adverse events: Assessment will be carried out according to the Medical Dictionary for Regulatory Dependencies (MedDRA).<br>Clinical laboratory tests: Panels of hematology and serum chemistry, urinalysis.<br>Gastrin levels: the test will be performed after patients have fasted for at least 10 hours<br>Vital signs: Measurement of blood pressure (after the patient has been sitting for at least 3 minutes), pulse rate and respiratory rate counted for at least 30 seconds and oral temperature.<br>Measure:Safety of treatment: Incidence of adverse events, clinical laboratory tests, gastrin levels and vital signs.<br>Timepoints:Day -1 and weeks 4 and 8.<br>
- Secondary Outcome Measures
Name Time Method