Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

NCT ID: NCT00251758

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 908 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2006-05-31

Brief Summary

The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).

Detailed Description

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a Screening Period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (NCT00241745) and T-GD04-083 (this posting, NCT00251758), were combined and analyzed as a single larger study, referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexlansoprazole MR 60 mg QD

Group Type: EXPERIMENTAL

Dexlansoprazole MR

Intervention Type: DRUG

Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.

Dexlansoprazole MR 90 mg QD

Group Type: EXPERIMENTAL

Dexlansoprazole MR

Intervention Type: DRUG

Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Interventions

Dexlansoprazole MR

Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.

Intervention Type: DRUG

Dexlansoprazole MR

Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.

Intervention Type: DRUG

Placebo

Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

TAK-390MR; Kapidex; Dexilant; TAK-390MR; Kapidex; Dexilant

Eligibility Criteria

Inclusion Criteria

• Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.

• History of episodes of heartburn for 6 months or longer prior to screening.
• History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

Exclusion Criteria

• Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
• Erosive Esophagitis seen on endoscopy during study screening.
• Co-existing diseases affecting the esophagus.
• Abnormal laboratory values that suggest significant clinical disease.
• Known acquired immunodeficiency syndrome (AIDS)
• Females pregnant or lactating.
• History of Alcohol abuse.
• History of Cancer within 3 years prior to screening.
• Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
• Use of antacids (except for study supplied Gelusil® )
• Use of drugs with significant anticholinergic effects
• Need for continuous anticoagulant (blood thinner) therapy
• Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
• History of dilatation of esophageal strictures, other than a 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
• Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
• Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Takeda Global Research & Development Center, Inc.

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Anniston, Alabama, United States

Hueytown, Alabama, United States

Huntsville, Alabama, United States

Tallassee, Alabama, United States

Tuscaloosa, Alabama, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

North Little Rock, Arkansas, United States

Azusa, California, United States

Carmichael, California, United States

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

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

Sarasota, Florida, United States

St. Petersburg, Florida, United States

Zephyrhills, Florida, United States

Atlanta, Georgia, United States

Champaign, Illinois, United States

Moline, Illinois, United States

North Chicago, Illinois, United States

Oak Forest, Illinois, United States

Springfield, Illinois, United States

Evansville, Indiana, United States

Indianapolis, Indiana, United States

Newburgh, Indiana, United States

Davenport, Iowa, United States

Kansas City, Kansas, United States

Wichita, Kansas, United States

Lexington, Kentucky, United States

Louisville, 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

St Louis, Missouri, United States

Missoula, Montana, United States

Egg Harbor, 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

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

Medford, Oregon, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Warwick, Rhode Island, United States

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

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Odessa, Texas, United States

Pharr, 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

Bellevue, Washington, United States

Lakewood, Washington, United States

Tacoma, Washington, United States

Milwaukee, Wisconsin, United States

Countries

United States

Related Links

http://general.takedapharm.com/content/file/pi.pdf?applicationcode=9efb34b3-fb69-4190-a2be-a90b8cb94e25&filetypecode=DEXILANTPI

For the Dexilant Package Insert refer to this link

Other Identifiers

U1111-1114-1811

Identifier Type: REGISTRY

Identifier Source: secondary_id

T-GD04-083

Identifier Type: -

Identifier Source: org_study_id