A Study to Compare the Efficacy and Safety of TAK-390MR and Lansoprazole on Healing of Erosive Esophagitis

This is a study to assess the efficacy and safety of 8 weeks of treatment with TAK-390MR (60 mg daily and 90 mg daily) compared to lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

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

Conditions

Erosive Esophagitis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcomes:

Percentage of subjects with complete healing of erosive esophagitis over 8 weeks as assessed by endoscopy.

Secondary Outcomes:

Percentage of subjects with complete healing of erosive esophagitis after 4 weeks of treatment as assessed by endoscopy.; Percentage of subjects with baseline esophagitis grade C or D combined who have complete healing of erosive esophagitis over 8 weeks as assessed by endoscopy.

Study start: November 2005; Expected completion: October 2007

Last follow-up: March 2007; Data entry closure: May 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 TAK-390MR (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.

Study Start

November 2005

Eligibility & Criteria

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 Barretts esophagus and/or definite dysplastic changes in the esophagus
• History of dilatation of esophageal strictures, other than Schatzkis 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.

Total Enrolment

Expected Total Enrollment: 1950

Contact Details

Bedford Park, Australia