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 treatment with Dexlansoprazole (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

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 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.

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 (UGI) hemorrhage within 4 weeks of the Screening

endoscopy

Bedford Park, Australia

Adelaide, Australia

Kippa Ring, Australia

Sofia, Bulgaria

Barranquilla - Atlantico, Colombia

Hradec Kralove, Czech Republic

Ostrava - Hrabuvka, Czech Republic

Bratislava, Germany

Pune, India

Hyderabad, India

Balvi, Latvia

Valmiera, Latvia

Riga, Latvia

Panevezys, Lithuania

Vinius, Lithuania

Auckland, New Zealand

Lima, Peru

Bialystok, Poland

Bydgoszcz, Poland

Krakow, Poland

Mangalore, Poland

Warszawa, Poland

Moscow, Russian Federation

Yaroslavi, Russian Federation

St. Petersburg, Russian Federation

Daugavpils, Slovakia

Kosice, Slovakia

Presov, Slovakia

Parktown, Gauteng, South Africa

Anniston, Alabama, United States

Hueytown, Alabama, United States

Huntsville, Alabama, United States

Tallassee, Alabama, United States

Tuscaloosa, Alabama, United States

Hyderabad, Andh Prad, India

Tucson, Arizona, United States

Little Rock, Arkansas, United States

North Little Rock, Arkansas, United States

Berlin, BE, Germany

Stuttgart, BW, Germany

Cundinamarca, Bogota, Colombia

Cypress, California, United States

Fresno, California, United States

Los Angeles, California, United States

Modesto, California, United States

Newport Beach, California, United States

Oakland, California, United States

Orange, California, United States

San Diego, California, United States

Santa Maria, California, United States

Carmichael, California, United States

Azusa, California, United States

Littleton, Colorado, United States

Longmont, Colorado, United States

Wheat Ridge, Colorado, United States

Bristol, Connecticut, United States

Newark, Delaware, United States

Fort Myers, Florida, United States

Miami, Florida, United States

Naples, Florida, United States

New Smyrna Beach, Florida, United States

Ocala, Florida, United States

Pembroke Pines, Florida, United States

Port Orange, Florida, United States

Saint Petersburg, Florida, United States

Sarasota, Florida, United States

Zephyrhills, Florida, United States

Bloemfontein, Free State, South Africa

Atlanta, Georgia, United States

Hamburg, HH, Latvia

Boise, Idaho, United States

Moline, Illinois, United States

North Chicago, Illinois, United States

Oak Forest, Illinois, United States

Evansville, Indiana, United States

Indianapolis, Indiana, United States

Newburgh, Indiana, United States

Davenport, Iowa, United States

Bangalore, Kama, India

Kansas City, Kansas, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Lexington, Kentucky, United States

Baton Rouge, Louisiana, United States

Chevy Chase, Maryland, United States

Prince Frederick, Maryland, United States

Jackson, Mississippi, United States

Jefferson City, Missouri, United States

Kansas City, Missouri, United States

Saint Louis, Missouri, United States

Missoula, Montana, United States

Bochum, NW, Germany

Egg Harbor Township, New Jersey, United States

Albuquerque, New Mexico, United States

Charlotte, North Carolina, United States

Greensboro, North Carolina, United States

High Point, North Carolina, United States

Raleigh, North Carolina, United States

Wilmington, North Carolina, United States

Winston-Salem, North Carolina, United States

Harrisburg, North Carolina, United States

Chapel Hill, North Carolina, United States

Bismarck, North Dakota, United States

Akron, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Mogadore, Ohio, United States

Oklahoma City, Oklahoma, United States

Hamilton, Ontario, Canada

Newmarket, Ontario, Canada

Medford, Oregon, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Ludhiana, Punjab, India

Montreal, Quebec, Canada

Warwick, Rhode Island, United States

Saskatoon, Saskatchewan, Canada

Anderson, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Sioux Falls, South Dakota, United States

Chattanooga, Tennessee, United States

Germantown, Tennessee, United States

Jackson, Tennessee, United States

Johnson City, Tennessee, United States

Kingsport, Tennessee, United States

Amarillo, Texas, United States

Conroe, Texas, United States

Pharr, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Odessa, Texas, United States

Seguin, Texas, United States

Temple, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Cape Town, WC, South Africa

Observatory, Cape Town, WC, South Africa

Bellevue, Washington, United States

Lakewood, Washington, United States

Tacoma, Washington, United States

Milwaukee, Wisconsin, United States

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