Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

Detailed Description
-----------------
This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last up to 8 weeks.

Official Title
-----------------
A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once-daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis

Conditions
-----------------
Esophagitis, Reflux, Esophagitis, Peptic

Intervention / Treatment
-----------------
* Drug: Dexlansoprazole MR
* Drug: Dexlansoprazole MR
* Drug: Lansoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D). Exclusion Criteria: Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics Use of antacids [except for study supplied Gelusil®] Need for continuous anticoagulant therapy (Blood Thinners) Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexlansoprazole MR 60 mg QD<br> | Drug: Dexlansoprazole MR<br>* Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.<br>* Other names: Dexilant;|
| Experimental: Dexlansoprazole MR 90 mg QD<br> | Drug: Dexlansoprazole MR<br>* Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.<br>* Other names: Dexilant;|
| Active Comparator: Lansoprazole 30 mg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.<br>* Other names: AG-1749;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. | Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed. | 8 Weeks | 
| Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method | Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. | Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. | Week 8 | 
| Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method. | Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. | 8 Weeks | 
| Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis. | Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. | 4 Weeks | 
| Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method | Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. | 4 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erosive Esophagitis