Phase
Condition
Gastroesophageal Reflux Disease (Gerd)
Esophageal Disorders
Heartburn (Pediatric)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Prior to any study-specific procedures being performed, the participant voluntarilysigns an Investigational Review Board-approved informed consent form (ICF) and anyprivacy statement/authorization form required (eg, The Health Insurance Portabilityand Accountability Act (HIPAA) authorization)
Has a history of gastroesophageal reflux disease symptom, including heartburn, priorto 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 equalto 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 orbe of non-childbearing potential. If females are of child bearing potential, must havea negative serum human chorionic gonadotropin (hCG) pregnancy test during Screeningand on an acceptable form of contraception, or have had bilateral tubal ligation ifperformed a minimum of 90 days prior to Day 1.
Exclusion
Exclusion Criteria:
Has a history of co-existing diseases affecting the esophagus, history of radiationtherapy or cryotherapy to the esophagus, caustic or physiochemical trauma such assclerotherapy 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 otherhypersecretory condition.
Has known hypersensitivity to any proton pump inhibitor or any component ofdexlansoprazole MR.
Use of any Histamine type-2 receptor antagonist or antacids during Screening oranticipated use during the study treatment period.
Use of the following medications 7 days prior to Screening or anticipated use duringthe study:
Sucralfate.
Misoprostol.
Systemic corticosteroids.
Prokinetics (to include metoclopramide, cisapride, tegaserod).
Bisphosphonates during the 6 months prior to Screening or anticipated use duringthe study.
Chronic use (> 12 doses per month) of nonsteroidal anti-inflammatory drugs
Drugs with significant anticholinergic effects such as tricyclic antidepressantsor drugs with central nervous system effects that could mask perception ofsymptoms.
Any investigational drug(s) within 30 days of Screening.
Has received blood products within the 3 months prior to Screening.
History of alcohol abuse or illegal drug use or drug addiction in the 12 months priorto Screening.
Evidence of uncontrolled, clinically significant neurologic, cardiovascular,pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or otherabnormality, which may impact the ability of the participant to participate orpotentially confound the study results.
Atypical manifestations of gastroesophageal reflux disease.
Has abnormal screening laboratory values that suggest a clinically significantunderlying disease or condition.
Cancer within 5 years prior to Screening.
Is known to have acquired immunodeficiency syndrome.
Has any condition that is likely to require inpatient surgery during the course of thestudy.
Surgery of the acute upper gastrointestinal tract, including bariatric.
Is in the opinion of the investigator unable to comply with the requirements of thestudy or are unsuitable for any reason.
Study Design
Study Description
Connect with a study center
Hueytown, Alabama
United StatesSite Not Available
Chandler, Arizona
United StatesSite Not Available
Sierra Vista, Arizona
United StatesSite Not Available
Tucson, Arizona
United StatesSite Not Available
Sherman, Arkansas
United StatesSite Not Available
Sherwood, Arkansas
United StatesSite Not Available
Carmichael, California
United StatesSite Not Available
Garden Grove, California
United StatesSite Not Available
Laguna Hills, California
United StatesSite Not Available
Long Beach, California
United StatesSite Not Available
Paramount, California
United StatesSite Not Available
Rancho Cucamonga, California
United StatesSite Not Available
Roseville, California
United StatesSite Not Available
Sacramento, California
United StatesSite Not Available
San Diego, California
United StatesSite Not Available
San Ramon, California
United StatesSite Not Available
Tustin, California
United StatesSite Not Available
Westlake Village, California
United StatesSite Not Available
Bristol, Connecticut
United StatesSite Not Available
Boynton Beach, Florida
United StatesSite Not Available
Hialeah, Florida
United StatesSite Not Available
New Smyrna Beach, Florida
United StatesSite Not Available
Winter Haven, Florida
United StatesSite Not Available
Augusta, Georgia
United StatesSite Not Available
Conyers, Georgia
United StatesSite Not Available
Newman, Georgia
United StatesSite Not Available
Stockbridge, Georgia
United StatesSite Not Available
Rockford, Illinois
United StatesSite Not Available
Metairie, Louisiana
United StatesSite Not Available
Prince Frederick, Maryland
United StatesSite Not Available
Stevensville, Michigan
United StatesSite Not Available
Olive Branch, Mississippi
United StatesSite Not Available
Egg Harbor Township, New Jersey
United StatesSite Not Available
Albuquerque, New Mexico
United StatesSite Not Available
Rochester, New York
United StatesSite Not Available
Wilmington, North Carolina
United StatesSite Not Available
Columbus, Ohio
United StatesSite Not Available
Oklahoma City, Oklahoma
United StatesSite Not Available
Yukon, Oklahoma
United StatesSite Not Available
Portland, Oregon
United StatesSite Not Available
Lansdale, Pennsylvania
United StatesSite Not Available
Salisbury, South Carolina
United StatesSite Not Available
Chattanooga, Tennessee
United StatesSite Not Available
Johnson City, Tennessee
United StatesSite Not Available
Nashville, Tennessee
United StatesSite Not Available
Dallas, Texas
United StatesSite Not Available
El Paso, Texas
United StatesSite Not Available
Houston, Texas
United StatesSite Not Available
South Ogden, Utah
United StatesSite Not Available
Chesapeake, Virginia
United StatesSite Not Available
Norfolk, Virginia
United StatesSite Not Available
Lakewood, Washington
United StatesSite Not Available
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