Phase
Condition
Esophageal Disorders
Heartburn (Pediatric)
Heartburn
Treatment
Dexlansoprazole
Clinical Study ID
Ages 2-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
In the opinion of the investigator, the participant (as age appropriate) and/orparent(s) or legal guardian are capable of understanding and complying with protocolrequirements.
Prior to any study-specific procedures being performed, the appropriate screeninginformed consent and the assent forms (as applicable) must be signed and dated byparent(s) or legal guardian and by the participant respectively, if appropriate.
Has a medical history of symptoms of GERD for at least 3 months prior to Screening.
Has met the eDiary qualification criteria as assessed by the PGSDD, defined ashurting or burning in the stomach, chest, or throat on at least 3 of any 7consecutive days during the Screening Period. (Note: If an endoscopy performedwithin 1 week of signing screening informed consent and assent [as applicable] isused to confirm diagnosis of EE, the participant does not need to meet thiscriterion).
Has endoscopic evidence of EE with Los Angeles (LA) Grade A to D based on thescreening endoscopy performed either during the Screening Period or within 1 weekprior to signing screening informed consent and assent (as applicable). An endoscopythat was performed within 1 week prior to signing screening informed consent andassent, as applicable, is an acceptable replacement for the Screening endoscopy ifEE is documented by LA classification scale criterion previously described,protocol-required biopsies were collected and endoscopic pictures were obtained.
Is male or female and age 2 to 11 years, inclusive, at the time of screeninginformed consent.
Exclusion
Exclusion Criteria:
Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergicskin rash that suggests any uncontrolled, clinically significant underlying diseaseor condition (other than the disease being studied), which may impact the ability ofthe participant to participate or potentially confound the study results.
Has a coexisting disease affecting the esophagus (eg, esophageal varices,scleroderma, viral or fungal infection, or esophageal stricture), history ofradiation therapy or cryotherapy to the esophagus, caustic or physiochemical traumasuch as sclerotherapy to the esophagus.
Has any findings in his/her medical history, physical examination, or safetyclinical laboratory tests giving reasonable suspicion of underlying disease thatmight interfere with the conduct of the trial.
Has a history of hypersensitivity or allergies to dexlansoprazole or any componentof dexlansoprazole capsules or any PPI (including lansoprazole, omeprazole,rabeprazole, pantoprazole, or esomeprazole) or antacids.
Is required to take excluded medications or it is anticipated that the participantwill require treatment with at least 1 of the disallowed concomitant medicationsduring the study evaluation period.
Has a condition that may require inpatient surgery during the course of the study.
Has a known history of Barrett's with dysplastic changes in the esophagus.
Has a known history of eosinophilic esophagitis (EoE) or histologic findingssuggestive of EoE (≥15 eosinophils per high-powered field [HPF]).
Has history of celiac disease, tests positive for tissue transglutaminase (tTG)antibody, or has confirmed disease by histology.
Has history of inflammatory bowel disease, or irritable bowel syndrome.
Has active gastric or duodenal ulcers within 4 weeks prior to Day -1. If present >4weeks prior to Day -1, ulcers must not be present upon screening endoscopy.
Requires dilatation of esophageal strictures and/or strictures preventing passage ofthe endoscope during the Screening endoscopy. Schatzki's ring (a ring of mucosaltissue near the lower esophageal sphincter) is acceptable.
A female participant who has reached menarche by Day -1.
Is known to be positive for the human immunodeficiency virus (HIV).
Has current or clinical history of Zollinger-Ellison syndrome or otherhypersecretory condition.
Has a history of gastric, duodenal, or esophageal surgery except simple oversew ofan ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG)placement is allowed.
Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.
Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or hashad a transfusion of any blood product within 90 days prior to the first dose ofstudy drug.
Has a known history of alcohol abuse or illegal drug use within the past 12 monthsprior to the first dose of study drug.
Has any screening abnormal laboratory value that suggests a clinically significantunderlying disease or condition that may prevent the participant from entering thestudy; or the participant has: creatinine >1.5 milligrams per deciliter (mg/dL),alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times theupper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevatedabove the limits of normal values.
Is an immediate family member, study site employee, or is in a dependentrelationship with a study site employee who is involved in the conduct of this studyor may consent and assent under duress. Students of the institution/researchfacility who are under the supervision of, or in a subordinate role to, theinvestigator are also ineligible.
The participant, in the opinion of the investigator, is unlikely to comply with theprotocol or is unsuitable for any other reason.
Has participated in another clinical study (not including screening for StudyTAK-390MR_204 [NCT02616302]) and/or has received any investigational compound within 30 days prior to Screening.
Tests positive for Helicobacter pylori.
Study Design
Study Description
Connect with a study center
Universitair Ziekenhuis Brussel
Bruxelles, 1090
BelgiumSite Not Available
CHC - Cliniques de l'Esperance
Montegnee, 4420
BelgiumSite Not Available
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande Do Sul 99010-080
BrazilSite Not Available
Hospital Israelita Albert Einstein
Sao Paulo, 05651-901
BrazilSite Not Available
Women and Children's Health Research Institute
Edmonton, Alberta T6G 1C9
CanadaSite Not Available
London Health Sciences Centre (LHSC) - Children's Hospital
London, Ontario N6A 5W9
CanadaSite Not Available
Hospital Universitario San Ignacio
Bogota, 110231
ColombiaSite Not Available
Centro Medico Imbanaco de Cali S.A
Cali, 760042
ColombiaSite Not Available
Fundacion Valle del Lili
Cali, 760032
ColombiaSite Not Available
HaEmek Medical Center
Afula, 18341
IsraelSite Not Available
Soroka University Medical Center
Beer Sheva, 8410101
IsraelSite Not Available
Assaf Harofeh M.C
Beer Yaakov, 70300
IsraelSite Not Available
Rambam Health Care Campus
Haifa, 3109601
IsraelSite Not Available
Hadassah University Hospital-Mt. Scopus
Jerusalem, 9112001
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 52621
IsraelSite Not Available
The Baruch Padeh MC, Poriya
Tiberias, 1520800
IsraelSite Not Available
Azienda Ospedaliera Universitaria "Federico II"
Napoli, 80131
ItalySite Not Available
Ospedale Pediatrico Bambino Gesu
Roma, 00165
ItalySite Not Available
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, LT-50161
LithuaniaActive - Recruiting
Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, LT-08661
LithuaniaActive - Recruiting
Boca Clinical Trials Mexico SC
Colonia Las Americas, Distrito Federal 1120
MexicoSite Not Available
Mexico Centre for Clinical Research S.A de C.V
Mexico, Distrito Federal 3100
MexicoSite Not Available
Clinical Research Institute S.C.
Tlalnepantla, Estado De Mexico 54055
MexicoActive - Recruiting
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, Michoacan 58260
MexicoSite Not Available
Inspirepharma S. de R.L. de C.V.
Monterrey, Nuevo Leon 64660
MexicoSite Not Available
El Cielo Medical Center
Puebla, 72160
MexicoActive - Recruiting
SMIQ S. de R.L. de C.V.
Queretaro, 76070
MexicoActive - Recruiting
Sociedad de Metabolismo y Corazon, S.C.
Veracruz, 91910
MexicoSite Not Available
In Vivo Osrodek Badan Klinicznych
Bydgoszcz, Kuyavia 85-048
PolandActive - Recruiting
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Malopolskie 30-663
PolandSite Not Available
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warszawa, Masovia 04-730
PolandSite Not Available
Gabinet Lekarski Bartosz Korczowski
Rzeszow, Podkarpackie 35-302
PolandActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Worclaw, 50-369
PolandSite Not Available
Hospital de Braga
Braga, 4710-243
PortugalSite Not Available
Hospital Pediatrico de Coimbra
Coimbra, 3000-602
PortugalSite Not Available
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital Dona Estefania- Servico de Gastroenterologia
Lisboa, 1169-045
PortugalSite Not Available
Centro Hospitalar de Sao Joao, E.P.E.
Porto, 4200-319
PortugalSite Not Available
University of South Alabama
Mobile, Alabama 36604
United StatesActive - Recruiting
Arizona Center for Clinical Trials LLC
Phoenix, Arizona 85003
United StatesSite Not Available
University of Arizona
Tucson, Arizona 85724
United StatesSite Not Available
Children's Hospital Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94158
United StatesSite Not Available
D&H National Research Centers
Miami, Florida 33155
United StatesActive - Recruiting
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia 30342
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Willis-Knighton Physician Network
Shreveport, Louisiana 71101
United StatesSite Not Available
Gastrointestinal Associates, PA
Flowood, Mississippi 39232
United StatesActive - Recruiting
University of Mississippi
Jackson, Mississippi 39216
United StatesSite Not Available
Children's Mercy Hospital
Kansas City, Missouri 64108
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Pediatric Pharmacology Research Center
Toledo, Ohio 43606
United StatesSite Not Available
Measurable Outcome Research
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
GI for Kids
Knoxville, Tennessee 37922
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Children's Hospital -Research Resource Office
Houston, Texas 77030
United StatesSite Not Available
Envision Clinical Research, LLC
Laredo, Texas 78041
United StatesActive - Recruiting
Primary Children's Medical Center
Salt Lake City, Utah 84108
United StatesSite Not Available
The Children's Hospital of The King's Daughters
Norfolk, Virginia 23507
United StatesActive - Recruiting
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