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

NCT00251693

U1111-1113-9373 (Registry Identifier)

T-EE04-084

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg 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 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 8 weeks.

Enrollment: 2,038 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 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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2,038 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