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

This is a study to assess the efficacy and safety of 8 weeks of once-daily treatment with Dexlansoprazole 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2007

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 (60 mg QD and 90 mg QD) 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.

Intervention(s) in this Clinical Trial

• Drug: Dexlansoprazole
  • 60 mg capsule orally once daily for up to 8 weeks
• Drug: Dexlansoprazole
  • 90 mg capsule orally once daily for up to 8 weeks
• Drug: Lansoprazole
  • 30 mg capsule orally once daily for up to 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Dexlansoprazole
• Experimental: 2
  • Dexlansoprazole
• Active Comparator: 3
  • Lansoprazole

Primary Measures

• Percentage of subjects with complete healing of erosive esophagitis as assessed by endoscopy.
  • Time Frame: week 8
    Safety Issue?: No

Secondary Measures

• Percentage of subjects with complete healing of erosive esophagitis as assessed by endoscopy.
  • Time Frame: Week 4
    Safety Issue?: No
• Percentage of subjects with baseline esophagitis grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy.
  • Time Frame: Week 8
    Safety Issue?: No

Inclusion Criteria:

• Subject must have endoscopically confirmed erosive esophagitis as defined by the Los
• Angeles (LA) Classification Grading System (A-D)
• Subjects sero-positive for H. pylori who have received appropriate eradication therapy during the past 6 months

Exclusion Criteria:

• Subject has a positive CLO test for 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 hemorrhage within 4 weeks of the screening endoscopy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair Takeda Global Research & Development Center, Inc.  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00251693

Study ID Number: T-EE04-084

ClinicalTrials.gov Identifier: NCT00251693

Health Authority: United States: Food and Drug Administration