Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

May 12, 2010 updated by: Takeda

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

908

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
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
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 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 60 mg, capsules, orally, once daily for 4 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Time Frame: 4 weeks
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.
4 weeks
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Time Frame: 4 weeks
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Time Frame: 4 weeks
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.
4 weeks
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Time Frame: 4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 10, 2005

Study Record Updates

Last Update Posted (Estimate)

May 18, 2010

Last Update Submitted That Met QC Criteria

May 12, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-GD04-083
  • U1111-1114-1811 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe