AzTrials
AzTrials

Gastroesophageal Reflux DiseasePhase 3NCT00251758

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

A Phase 3 study testing Dexlansoprazole MR in people with Gastroesophageal Reflux Disease, run by Takeda at 99 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
Dexlansoprazole MR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
908 participants
Where
99 sitesUnited States
Study dates
Dec 2005to May 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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

Trial locations and contacts

99 sites in 1 country.

99 sites in 1 country

United States99 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Anderson, South Carolina

  • Study site

    Anniston, Alabama

  • Study site

    Atlanta, Georgia

  • Study site

    Azusa, California

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bellevue, Washington

  • Study site

    Bismarck, North Dakota

  • Study site

    Bristol, Connecticut

  • Study site

    Carmichael, California

  • Study site

    Champaign, Illinois

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chevy Chase, Maryland

  • Study site

    Columbus, Ohio

  • Study site

    Conroe, Texas

  • Study site

    Cypress, California

  • Study site

    Dallas, Texas

  • Study site

    Davenport, Iowa

  • Study site

    Dayton, Ohio

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Evansville, Indiana

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fresno, California

  • Study site

    Germantown, Tennessee

  • Study site

    Greensboro, North Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Hueytown, Alabama

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Mississippi

  • Study site

    Jackson, Tennessee

  • Study site

    Jefferson City, Missouri

  • Study site

    Johnson City, Tennessee

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    Lakewood, Washington

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Littleton, Colorado

  • Study site

    Longmont, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Medford, Oregon

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Missoula, Montana

  • Study site

    Modesto, California

  • Study site

    Mogadore, Ohio

  • Study site

    Moline, Illinois

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Naples, Florida

  • Study site

    New Smyrna Beach, Florida

  • Study site

    Newark, Delaware

  • Study site

    Newburgh, Indiana

  • Study site

    Newport Beach, California

  • Study site

    Norfolk, Virginia

  • Study site

    North Chicago, Illinois

  • Study site

    North Little Rock, Arkansas

  • Study site

    Oak Forest, Illinois

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pharr, Texas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Port Orange, Florida

  • Study site

    Portland, Oregon

  • Study site

    Prince Frederick, Maryland

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    Santa Maria, California

  • Study site

    Sarasota, Florida

  • Study site

    Seguin, Texas

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Springfield, Illinois

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tacoma, Washington

  • Study site

    Tallassee, Alabama

  • Study site

    Temple, Texas

  • Study site

    Tucson, Arizona

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Warwick, Rhode Island

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wichita, Kansas

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Zephyrhills, Florida

Other trials in United States

About this study

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)

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).

Read the 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.

Being tested
Dexlansoprazole MR, Placebo
Keywords
Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Kapidex, Dexilant

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

  • Dexlansoprazole MRDrug

    Also called TAK-390MR, Kapidex, Dexilant

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

  • PlaceboDrug

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

Study groups in NCT00251758
Study groupRoleWhat they receive
Dexlansoprazole MR 60 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole MR
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

    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.

    Measured: 4 weeks

  2. Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

    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.

    Measured: 4 weeks

Secondary outcomes (2)

  1. Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

    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.

    Measured: 4 weeks

  2. Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

    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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
908 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251758
Sponsor's protocol ID
T-GD04-083
Other IDs
U1111-1114-1811
Status last verified
May 2010
First submitted
8 Nov 2005
Last updated
18 May 2010
Data monitoring committee
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexlansoprazole MR in people with Gastroesophageal Reflux Disease, run by Takeda at 99 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in