Efficacy and Safety of Dexlansoprazole and Lansoprazole on Healing of Erosive Esophagitis - Full Text View

Sponsor:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00251719

Purpose

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.

Condition	Intervention	Phase
Esophagitis, Reflux Esophagitis, Peptic	Drug: Dexlansoprazole MR Drug: Lansoprazole	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 8 Weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment:	2054
Study Start Date:	December 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dexlansoprazole MR Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
2: Experimental	Drug: Dexlansoprazole MR Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
3: Active Comparator	Drug: Lansoprazole Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251719

Show 144 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

For the Kapidex Package Insert refer to this link This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to this link This link exits the ClinicalTrials.gov site

Publications:

Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers:	T-EE04-085
Study First Received:	November 8, 2005
Results First Received:	February 20, 2009
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00251719 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Erosive Esophagitis

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Esophagitis
Esophagitis, Peptic

Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole
Gastroenteritis
Peptic Ulcer

ClinicalTrials.gov processed this record on February 08, 2010