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Gastroesophageal RefluxPhase 3NCT00627016

A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

A Phase 3 study testing Dexlansoprazole in people with Gastroesophageal Reflux, run by Takeda at 43 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Gastroesophageal Reflux
What is being tested?
Dexlansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
43 sitesUnited States
Study dates
Mar 2008to Mar 2009
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • History of nocturnal heartburn and GERD associated sleep disturbances prior to screening.
  • Meets both of the following criteria: 1) nocturnal heartburn severity of moderate, severe, or very severe on at least 3 of 7 nights and; 2) GERD related sleep disturbances on at least 3 of 7 nights.
  • Subjects must have history of symptomatic GERD prior to screening with GERD symptoms that were responsive to acid-suppressive therapy.

Who cannot join

  • Erosive esophagitis visualized during the screening endoscopy.
  • Allergy to any proton pump inhibitor drug (lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole), any component of Dexlansoprazole, or Gelusil/antacid.
  • Active gastric or duodenal ulcers within 30 days prior to randomization.
  • Upper gastrointestinal bleeding within 6 months prior to randomization.
  • Co-existing diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, and/or Barrett's esophagus).
  • History of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
Show all 20Show fewer
  • Subject requiring dilation for esophageal strictures and/or strictures preventing passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) is acceptable.
  • Has another condition that could be the primary cause of the subject's sleep disturbance.
  • Evidence of uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied) which may impact the ability of the subject to participate or potentially confound the trial results.
  • Diagnosis of cancer (except basal cell carcinoma) within 5 years of screening.
  • Has a condition likely to require surgery during the study.
  • Currently diagnosed with acquired immunodeficiency syndrome (AIDS).
  • Abnormal clinical laboratory values.
  • History of alcoholism or drug addiction.
  • Subject who works the night shift.
  • Subject who is planning to travel beyond 3 time zones during the study.
  • Chronic use (more than 12 doses/month) of non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX 2) inhibitors within 30 days prior to randomization or anticipated use during the study.
  • Use of the following medications during the 14 days prior to randomization or anticipated use during the study: proton pump inhibitors, sucralfate, misoprostol, corticosteroids, prokinetics, anticoagulant therapy, antiseizure medications (other than stable doses), psychotropic medications (other than stable doses), narcotic medications (occasional use allowed), bisphosphonates.
  • Use of sleep medications, first generation antihistamines, benzodiazepines, modified cyclic antidepressants, antianxiety medications or drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms (eg, selective-serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors). However, subjects who remain on a stable regimen and dose of these medications during the 90 days prior to randomization and who agree to maintain the same regimen and dose during the trial will qualify. Also, short term use of anticholinergics for trial related procedures is not exclusionary. Second generation antihistamines are not excluded.
  • Use of histamine (H2) receptor antagonists or antacids (except for trial supplied Gelusil) during the screening period or anticipated use during the treatment period.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Study site

    Anaheim, California

  • Study site

    Bristol, Tennessee

  • Study site

    Chattanooga, Tennessee

  • Study site

    Clive, Iowa

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Egg Harbor Town, New Jersey

  • Study site

    El Paso, Texas

  • Study site

    Fort Worth, Texas

  • Study site

    Garden Grove, California

  • Study site

    Great Neck, New York

  • Study site

    Greensboro, North Carolina

  • Study site

    Harrisburg, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Jefferson City, Missouri

  • Study site

    Johnson City, Tennessee

  • Study site

    Jupiter, Florida

  • Study site

    Kingsport, Tennessee

  • Study site

    Lancaster, California

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Mogadore, Ohio

  • Study site

    Moline, Illinois

  • Study site

    Monroe, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    New Smyrna Beach, Florida

  • Study site

    Norfolk, Virginia

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Portland, Oregon

  • Study site

    Prince Frederick, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Sherwood, California

  • Study site

    Spokane, Washington

  • Study site

    St. Petersburg, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Westlake Village, California

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Zephyrhills, Florida

Other trials in United States

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.

Read the detailed description

This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.

Being tested
Dexlansoprazole, Placebo
Keywords
Non-Erosive Gastroesophageal Reflux Disease, GERD, heartburn, sleep disturbance, nocturnal Reflux
Medical subject headings
Gastroesophageal Reflux, Heartburn, Parasomnias

What participants receive

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

  • DexlansoprazoleDrug

    Also called TAK-390, T-168390, TAK-390MR, Kapidex

    30 mg capsule, orally, once daily for 4 weeks

  • PlaceboDrug

    1 capsule, orally, once daily for 4 weeks

Study groups in NCT00627016
Study groupRoleWhat they receive
Dexlansoprazole 30 mg QDExperimentalNot described
Receives: Drug: Dexlansoprazole
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.

    Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.

    Measured: 4 Weeks

Secondary outcomes (2)

  1. Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.

    Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.

    Measured: Last 7 days of treatment

  2. Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.

    Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.

    Measured: Last 7 days of treatment

Timeline

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

  1. First posted29 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2009
  4. Study completionMar 2009

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
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00627016
Sponsor's protocol ID
T-GD07-170
Other IDs
U1111-1113-9537
Status last verified
Apr 2011
First submitted
21 Feb 2008
Last updated
28 Apr 2011
Data monitoring committee
No

Publications

  • Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.

    PubMed 21224838

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexlansoprazole in people with Gastroesophageal Reflux, run by Takeda at 43 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 4 inclusion and 20 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 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 6 May 2010). 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?

Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary. (time frame: 4 Weeks). 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 NCT00627016, which also lists 1 linked publication.

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 28 Apr 2011.

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