Actively Recruiting
A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old
Led by Takeda · Updated on 2026-01-14
70
Participants Needed
33
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Symptomatic nonerosive GERD is a condition where people have the symptoms of GERD but the esophagus has not been damaged. People of all ages can have GERD. The causes of GERD in children are similar to those in adults and teenagers. Dexlansoprazole is a medicine that has been shown to help relieve the symptoms of GERD in adults and teenagers. This study aims to find out if dexlansoprazole doses given to children with symptomatic nonerosive GERD, based on their body weight, helps them feel better.
CONDITIONS
Official Title
A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant and parent/legal guardian can understand and follow study requirements
- Signed informed consent by parent/legal guardian and assent by participant if appropriate
- History of GERD symptoms for at least 3 months before screening
- Meets electronic diary criteria of heartburn symptoms on at least 3 of 7 consecutive days during screening
- No evidence of erosive esophagitis by Los Angeles Classification
- Age between 2 and 11 years inclusive at screening
You will not qualify if you...
- Cardiovascular, pulmonary, nervous system, liver, blood, kidney, or metabolic disorders, severe allergy, asthma, or significant skin rash that may affect participation
- Diseases affecting the esophagus like varices, scleroderma, infections, strictures, or history of esophageal radiation or trauma
- Medical history or tests indicating diseases that may interfere with the study
- Allergies to dexlansoprazole, proton pump inhibitors, or antacids
- Use or anticipated need for disallowed medications during the study
- Conditions requiring inpatient surgery during the study
- History of Barrett's esophagus with dysplasia
- Known or suspected eosinophilic esophagitis
- History of celiac disease or positive tissue transglutaminase antibody test
- History of inflammatory bowel disease or irritable bowel syndrome
- Active gastric or duodenal ulcers within 4 weeks before Day -1
- Esophageal strictures preventing endoscope passage (except Schatzki's ring)
- Female participants who have reached menarche by Day -1
- Known HIV positive status
- History of Zollinger-Ellison syndrome or other hypersecretory conditions
- Prior gastric, duodenal, or esophageal surgery except simple ulcer oversew
- Acute upper gastrointestinal bleeding within 4 weeks before endoscopy
- Significant blood loss or transfusion within 90 days before first dose
- History of alcohol abuse or illegal drug use within 12 months before first dose
- Abnormal lab values indicating significant disease or condition
- Immediate family or dependent relationship with study staff
- Unlikely to comply with protocol or unsuitable for any reason
- Participation in another clinical trial or use of investigational drugs within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Childrens Center for Digestive Health Care, LLC
Mobile, Alabama, United States, 36604
Actively Recruiting
2
University of Utah/ Primary Childrens Hospital
San Francisco, California, United States, 94158
Actively Recruiting
3
Gastrointestinal Associates, PA
Centennial, Colorado, United States, 80112
Withdrawn
4
Envision Clinical Research, LLC
Miami, Florida, United States, 33155
Withdrawn
5
GI For Kids
Atlanta, Georgia, United States, 30342
Actively Recruiting
6
Strada Patient Care Center, Department of Pediatric Gastroenterology
Chicago, Illinois, United States, 60637
Withdrawn
7
Childrens Hospital of The Kings Daughters
Jackson, Mississippi, United States, 39232
Actively Recruiting
8
Maspons Pediatric Gastro
Manchester, New Hampshire, United States, 79902
Withdrawn
9
The University of Chicago
Cleveland, Ohio, United States, 44106
Actively Recruiting
10
Dartmouth-Hitchcock Manchester
Oklahoma City, Oklahoma, United States, 73104
Withdrawn
11
University of California San Francisco
Oklahoma City, Oklahoma, United States, 73112
Withdrawn
12
c/o Chelsea Campbell, RN
Knoxville, Tennessee, United States, 37922
Withdrawn
13
Vanderbilt University Medical Center,
Nashville, Tennessee, United States, 37212
Withdrawn
14
Oklahoma Pediatric Digestive Institute
El Paso, Texas, United States, 79902
Withdrawn
15
University Hospitals Cleveland Medical Center
Laredo, Texas, United States, 78041
Withdrawn
16
IMMUNOe Research Centers
Salt Lake City, Utah, United States, 84113
Withdrawn
17
National Research Centers
Norfolk, Virginia, United States, 23507
Actively Recruiting
18
Women and Children's Health Research Institute
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
19
London Health Sciences Centre Children's Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
20
Hospital Universitario San Ignacio
Bogotá, Colombia, 110231
Actively Recruiting
21
Fundacion Valle del Lili
Cali, Colombia, 760032
Actively Recruiting
22
Centro Medico Imbanaco de Cali S.A
Cali, Colombia, 760042
Actively Recruiting
23
Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Public Institution
Kaunas, LT, Lithuania, LT-50161
Withdrawn
24
Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, LT, Lithuania, LT-08406
Withdrawn
25
InspirePharma S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico, 64660
Withdrawn
26
Boca Clinical Trials Mexico S.C.
Querétaro, Putumayo, Mexico, 1120
Actively Recruiting
27
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, Mexico, 54055
Actively Recruiting
28
El Cielo Medical Center
Puebla City, Mexico, 72160
Actively Recruiting
29
SMIQ, S. DE R.L. DE C.V. Queretaro
Querétaro, Mexico, 76070
Actively Recruiting
30
Gabinet Lekarski Bartosz Korczowski
Rzeszów, PL, Poland, 35-302
Active, Not Recruiting
31
In Vivo Osrodek Badan Klinicznych
Bydgoszcz, Poland, 85-048
Active, Not Recruiting
32
Instytut "Pomnik - Centrum Zdrowia Dziecka", Oddzial Gastroenterologii, Hepatologii, Zaburzen odzywiania i Pediatrii
Warsaw, Poland, 04-730
Active, Not Recruiting
33
Uniwersytecki Szpital Kliniczny im.Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland, 50-369
Withdrawn
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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