A Study to Compare the Efficacy and Safety of Dexlansoprazole and Lansoprazole on Healing of Erosive Esophagitis

Condition(s) targeted: Esophagitis, Reflux; Esophagitis, Peptic

Intervention: Dexlansoprazole (Drug); Dexlansoprazole (Drug); Lansoprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: TAP Pharmaceutical Products Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.

This is a study to assess the efficacy and safety of 8 weeks of once-daily treatment with Dexlansoprazole 60 mg or 90 mg or lansoprazole 30 mg 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

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

Primary outcome: Percentage of subjects with complete healing of erosive esophagitis as assessed by endoscopy.

Secondary outcome:

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

Percentage of subjects with baseline esophagitis grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy.

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 (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 up to 8 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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

Box Hill, Australia

South Brisbane, Australia

Sofia, Bulgaria

Praha 6, Czech Republic

Gyula, Hungary

New Delhi, India

Vishakapatnam, India

Hyderabad, India

Chennai, India

Coimbatore, India

Riga, Latvia

Kaunas, Lithuania

Hamilton, New Zealand

Lima, Peru

Krakow, Poland

Lubin, Poland

Sopot, Poland

Warzawa, Poland

Bratislava, Slovakia

Nitra, Slovakia

Sucany, Slovakia

Tmava, Slovakia

Pretoria, South Africa

Gujarat, Ahmedabad, India

Alabaster, Alabama, United States

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Edmonton, Alberta, Canada

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Tucson, Arizona, United States

Anaheim, California, United States

Chula Vista, California, United States

Fullerton, California, United States

Garden Grove, California, United States

Lancaster, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Mission Hills, California, United States

Palm Springs, California, United States

Redwood City, California, United States

San Diego, California, United States

San Luis Obispo, California, United States

Irvine, California, United States

Pasadena, California, United States

Tamilnadu, Chennai, India

Boulder, Colorado, United States

Colorado Springs, Colorado, United States

Wheat Ridge, Colorado, United States

Lone Tree, Colorado, United States

Waterbury, Connecticut, United States

Boynton Beach, Florida, United States

Jupiter, Florida, United States

Kissimmee, Florida, United States

Lakeland, Florida, United States

New Port Richey, Florida, United States

Jacksonsville, Florida, United States

Atlanta, Georgia, United States

Dietzenback, HE, Germany

Hamburg, HH, Germany

Honolulu, Hawaii, United States

Arlington Heights, Illinois, United States

Chicago, Illinois, United States

Hines, Illinois, United States

Oak Park, Illinois, United States

Rockford, Illinois, United States

Clive, Iowa, United States

Dubuque, Iowa, United States

Rajasthan, Jaipur, India

Gauteng, Johannesburg, South Africa

Newton, Kansas, United States

Shawnee Mission, Kansas, United States

Topeka, Kansas, United States

Shreveport, Louisiana, United States

Metairie, Louisiana, United States

Winnipeg, Manitoba, Canada

Hollywood, Maryland, United States

Lutherville, Maryland, United States

Troy, Michigan, United States

Chaska, Minnesota, United States

Jackson, Mississippi, United States

Saint Louis, Missouri, United States

Washington, Missouri, United States

Mexico, Missouri, United States

Schweim, NW, Germany

Omaha, Nebraska, United States

Pahrump, Nevada, United States

Great Neck, New York, United States

Rochester, New York, United States

Binghamton, New York, United States

Brooklyn, New York, United States

St. John's, Newfoundland and Labrador, Canada

Charlotte, North Carolina, United States

Elkin, North Carolina, United States

Greensboro, North Carolina, United States

Hickory, North Carolina, United States

Salisbury, North Carolina, United States

Statesville, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Mayfield Heights, Ohio, United States

Warren, Ohio, United States

Beachwood, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Beaver Falls, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Lansdale, Pennsylvania, United States

Ludhiana, Punjab, India

Quebec City, Quebec, Canada

Borna, SN, Germany

Regina, Saskatchewan, Canada

Saskatoon, Saskatchewan, Canada

Madurai, Tamina, India

Bristol, Tennessee, United States

Hermitage, Tennessee, United States

Nashville, Tennessee, United States

Chattanooga, Tennessee, United States

Austin, Texas, United States

Byran, Texas, United States

Corsicana, Texas, United States

El Paso, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Beaumont, Texas, United States

Bountiful, Utah, United States

Ogden, Utah, United States

Salt Lake City, Utah, United States

West Jordan, Utah, United States

Chesapeake, Virginia, United States

Danville, Virginia, United States

Cape Town, WC, South Africa

Panorama, WC, South Africa

Pinelands, WC, South Africa

Plumstead, WC, South Africa

Somerset West, WC, South Africa

Spokane, Washington, United States

Milwaukee, Wisconsin, United States

Monroe, Wisconsin, United States

Starting date: December 2005
Ending date: January 2007
Last updated: June 13, 2008