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

Takeda

Status and phase: Completed; Phase 3

Conditions: Esophagitis, Peptic; Esophagitis, Reflux

Treatments: Drug: Dexlansoprazole MR; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00251719

U1111-1114-0058 (Registry Identifier)

T-EE04-085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,054 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,054 participants in 3 patient groups

Dexlansoprazole MR 60 mg QD

Experimental group

Treatment:

Drug: Dexlansoprazole MR

Drug: Dexlansoprazole MR

Dexlansoprazole MR 90 mg QD

Experimental group

Treatment:

Drug: Dexlansoprazole MR

Drug: Dexlansoprazole MR

Lansoprazole 30 mg QD

Active Comparator group

Treatment:

Drug: Lansoprazole