A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
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)
2 other identifiers
interventional
305
1 country
43
Brief Summary
The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2008
Shorter than P25 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
May 6, 2010
CompletedApril 28, 2011
April 1, 2011
1 year
February 21, 2008
March 18, 2010
April 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
4 Weeks
Secondary Outcomes (2)
Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.
Last 7 days of treatment
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.
Last 7 days of treatment
Study Arms (2)
Dexlansoprazole 30 mg QD
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
30 mg capsule, orally, once daily for 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (43)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Garden Grove, California, United States
Unknown Facility
Lancaster, California, United States
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Oakland, California, United States
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San Diego, California, United States
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Sherwood, California, United States
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Westlake Village, California, United States
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Jupiter, Florida, United States
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Miami, Florida, United States
Unknown Facility
New Smyrna Beach, Florida, United States
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Ocala, Florida, United States
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St. Petersburg, Florida, United States
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Zephyrhills, Florida, United States
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Moline, Illinois, United States
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Clive, Iowa, United States
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Wichita, Kansas, United States
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Metairie, Louisiana, United States
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Prince Frederick, Maryland, United States
Unknown Facility
Jefferson City, Missouri, United States
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Egg Harbor Town, New Jersey, United States
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Great Neck, New York, United States
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Greensboro, North Carolina, United States
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Harrisburg, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Mogadore, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Monroe, Wisconsin, United States
Related Publications (1)
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.
PMID: 21224838RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY CHAIR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 21, 2008
First Posted
February 29, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
April 28, 2011
Results First Posted
May 6, 2010
Record last verified: 2011-04