Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy
A Phase 3b Multicenter, Single-Blind Trial to Evaluate the Efficacy of Dexlansoprazole MR 30 mg in Maintaining Control of Gastroesophageal Reflux Disease Symptoms in Subjects on Prior Twice Daily Proton Pump Inhibitor Therapy
2 other identifiers
interventional
178
1 country
52
Brief Summary
The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2009
Shorter than P25 for phase_3
52 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
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
April 29, 2011
CompletedFebruary 3, 2012
February 1, 2012
1.2 years
February 18, 2009
April 5, 2011
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.
Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period.
Week 3 through Week 6
Secondary Outcomes (13)
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.
Baseline and Week 6.
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.
Baseline and Week 6.
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.
Baseline and Week 6.
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.
Baseline and Week 6.
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.
Baseline and Week 6.
- +8 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Eligibility Criteria
You may qualify if:
- Prior to any study-specific procedures being performed, the participant voluntarily signs an Investigational Review Board-approved informed consent form (ICF) and any privacy statement/authorization form required (eg, The Health Insurance Portability and Accountability Act (HIPAA) authorization)
- Has a history of gastroesophageal reflux disease symptom, including heartburn, prior to therapy, who are currently being treated with twice daily proton pump inhibitors, excluding Dexilant (dexlansoprazole).
- Taking a stable dose of any twice daily proton pump inhibitors for less than or equal to 1 year and greater than 8 weeks prior to Screening.
- Participant is well-controlled on their current twice daily proton pump inhibitors.
- Females cannot be nursing and must have a negative urine pregnancy test at Day -1 or be of non-childbearing potential. If females are of child bearing potential, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening and on an acceptable form of contraception, or have had bilateral tubal ligation if performed a minimum of 90 days prior to Day 1.
You may not qualify if:
- Has a history of co-existing diseases affecting the esophagus, history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
- Has active gastric or duodenal ulcers during the 30 days prior to Screening.
- Has acute upper gastrointestinal hemorrhage during the 30 days prior to Screening.
- Has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
- Has known hypersensitivity to any proton pump inhibitor or any component of dexlansoprazole MR.
- Use of any Histamine type-2 receptor antagonist or antacids during Screening or anticipated use during the study treatment period.
- Use of the following medications 7 days prior to Screening or anticipated use during the study:
- Sucralfate.
- Misoprostol.
- Systemic corticosteroids.
- Prokinetics (to include metoclopramide, cisapride, tegaserod).
- Bisphosphonates during the 6 months prior to Screening or anticipated use during the study.
- Chronic use (\> 12 doses per month) of nonsteroidal anti-inflammatory drugs
- Drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms.
- Any investigational drug(s) within 30 days of Screening.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (52)
Unknown Facility
Hueytown, Alabama, United States
Unknown Facility
Chandler, Arizona, United States
Unknown Facility
Sierra Vista, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Sherman, Arkansas, United States
Unknown Facility
Sherwood, Arkansas, United States
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Carmichael, California, United States
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Garden Grove, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
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Paramount, California, United States
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Rancho Cucamonga, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Ramon, California, United States
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Tustin, California, United States
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Westlake Village, California, United States
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Bristol, Connecticut, United States
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Boynton Beach, Florida, United States
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Hialeah, Florida, United States
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New Smyrna Beach, Florida, United States
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Winter Haven, Florida, United States
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Augusta, Georgia, United States
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Conyers, Georgia, United States
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Newnan, Georgia, United States
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Stockbridge, Georgia, United States
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Rockford, Illinois, United States
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Metairie, Louisiana, United States
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Prince Frederick, Maryland, United States
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Stevensville, Michigan, United States
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Olive Branch, Mississippi, United States
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Egg Harbor, New Jersey, United States
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Albuquerque, New Mexico, United States
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Rochester, New York, United States
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Wilmington, North Carolina, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Yukon, Oklahoma, United States
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Portland, Oregon, United States
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Lansdale, Pennsylvania, United States
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Salisbury, South Carolina, United States
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Chattanooga, Tennessee, United States
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Johnson City, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
Unknown Facility
El Paso, Texas, United States
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Houston, Texas, United States
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South Ogden, Utah, United States
Unknown Facility
Chesapeake, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Lakewood, Washington, United States
Related Publications (1)
Fass R, Inadomi J, Han C, Mody R, O'Neil J, Perez MC. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012 Mar;10(3):247-53. doi: 10.1016/j.cgh.2011.11.021. Epub 2011 Dec 7.
PMID: 22155561DERIVED
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 DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 3, 2012
Results First Posted
April 29, 2011
Record last verified: 2012-02