Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00251758
First received: November 8, 2005
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

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).


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Dexlansoprazole MR
Drug: Placebo
Phase 3

Takeda has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.

  • Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.


Secondary Outcome Measures:
  • Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.

  • Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.


Enrollment: 908
Study Start Date: December 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexlansoprazole MR 60 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Experimental: Dexlansoprazole MR 90 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Placebo Comparator: Placebo Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251758

  Hide Study Locations
Locations
United States, Alabama
Anniston, Alabama, United States
Hueytown, Alabama, United States
Huntsville, Alabama, United States
Tallassee, Alabama, United States
Tuscaloosa, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
North Little Rock, Arkansas, United States
United States, California
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
United States, Colorado
Littleton, Colorado, United States
Longmont, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Connecticut
Bristol, Connecticut, United States
United States, Delaware
Newark, Delaware, United States
United States, Florida
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
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Champaign, Illinois, United States
Moline, Illinois, United States
North Chicago, Illinois, United States
Oak Forest, Illinois, United States
Springfield, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Newburgh, Indiana, United States
United States, Iowa
Davenport, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Maryland
Chevy Chase, Maryland, United States
Prince Frederick, Maryland, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
United States, Montana
Missoula, Montana, United States
United States, New Jersey
Egg Harbor Township, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, North Carolina
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
United States, North Dakota
Bismarck, North Dakota, United States
United States, Ohio
Akron, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Mogadore, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Carolina
Anderson, South Carolina, United States
Mt. Pleasant, South Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Johnson City, Tennessee, United States
Kingsport, Tennessee, United States
United States, Texas
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
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Bellevue, Washington, United States
Lakewood, Washington, United States
Tacoma, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
No publications provided

Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00251758     History of Changes
Other Study ID Numbers: T-GD04-083, U1111-1114-1811
Study First Received: November 8, 2005
Results First Received: February 26, 2009
Last Updated: May 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014