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”

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.

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 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.

Intervention(s) in this Clinical Trial

• Drug: Dexlansoprazole MR
  • Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
• Drug: Dexlansoprazole MR
  • Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
• Drug: Lansoprazole
  • Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
  • Time Frame: 8 Weeks
    Safety Issue?: No
• Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method
  • Time Frame: 8 Weeks
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: Week 8
    Safety Issue?: No
• 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.
  • Time Frame: 8 Weeks
    Safety Issue?: No
• Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.
  • Time Frame: 4 Weeks
    Safety Issue?: No
• Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method
  • Time Frame: 4 Weeks
    Safety Issue?: No

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

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 Director Takeda Global Research & Development Center, Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00251719

Study ID Number: T-EE04-085

ClinicalTrials.gov Identifier: NCT00251719

Health Authority: United States: Food and Drug Administration

For the Kapidex Package Insert refer to this link

For FDA Safety Alerts and Recalls refer to this link