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
NCT ID: NCT02616302
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2023-02-20
2027-10-31
Brief Summary
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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.
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Detailed Description
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The study will enroll approximately 70 patients. Participants weighing ≤30 kilograms (kg) will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 15 or 30 milligrams (mg), and participants who weigh \>30 kg will be randomized to receive dexlansoprazole 30 or 60 mg.
All participants will be asked to take one capsule at the same time each day throughout the study. Parents/caregivers for participants ages 2 to 8 and participants ages 9 to 11 will be asked to record any time they have heartburn symptoms in an electronic diary.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 16 weeks, which includes up to 4 weeks to screen for the study. Participants will make multiple visits to the clinic, plus a final phone call 5 to 10 days after last dose of study drug for a follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Weight ≤30 kg: Dexlansoprazole 15 mg
Dexlansoprazole 15 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg.
Dexlansoprazole
Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
Weight ≤30 kg: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg.
Dexlansoprazole
Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
Weight >30 kg: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh \>30 kg.
Dexlansoprazole
Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
Weight >30 kg: Dexlansoprazole 60 mg
Dexlansoprazole 60 mg, capsules, once, daily, for 12 weeks. Participants weigh \>30 kg.
Dexlansoprazole
Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
Interventions
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Dexlansoprazole
Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prior to any study-specific procedures being performed, the appropriate informed consent and the assent form(s) (as applicable) must be signed and dated by parent(s) or legal guardian and by the participant respectively, if appropriate.
3. Has a medical history of symptoms of GERD for at least 3 months prior to Screening.
4. Has met the eDiary qualification criteria as assessed by the PGSDD, defined as hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive days during the Screening Period.
5. Has no evidence of erosive esophagitis (EE) according to the Los Angeles (LA) Classification of Esophagitis and, in the investigator's clinical judgment, the symptoms are suggestive of acid-related disease. A 24-hour pH-metry (with or without impedance) may be performed during Screening or within 6 months prior to Screening for similar symptoms as those identified during Screening if, in the investigator's judgment, this procedure would aid in the determination of whether the participant's symptoms are acid-related. An endoscopy performed within 1 week prior to signing screening informed consent and assent form (as applicable) is an acceptable replacement for the screening endoscopy if nonerosive GERD is confirmed, protocol-required biopsies were collected, and endoscopic pictures were obtained.
6. Is male or female and age 2 to 11 years, inclusive, at the time of screening informed consent.
Exclusion Criteria
2. Has a coexisting disease affecting the esophagus (eg, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
3. Has any findings in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
4. Has a history of hypersensitivity or allergies to dexlansoprazole or any component of the formulation of dexlansoprazole capsules, or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) or antacids.
5. Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period.
6. Has a condition that may require inpatient surgery during the course of the study.
7. Has a known history of Barrett's esophagus with dysplastic changes in the esophagus.
8. Has a known history of eosinophilic esophagitis (EoE) or histologic findings suggestive of EoE (≥15 eosinophils per high-powered field \[HPF\]).
9. Has history of celiac disease, tests positive for tissue transglutaminase (tTG), antibody or confirmed disease by histology.
10. Has history of inflammatory bowel disease, or irritable bowel syndrome.
11. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1. If present \>4 weeks prior to Day -1, ulcers must not be present upon screening endoscopy.
12. Requires dilatation of 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.
13. A female participant who has reached menarche by Day -1.
14. Is known to be positive for the human immunodeficiency virus (HIV).
15. Has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
16. Has a history of gastric, duodenal, or esophageal surgery except simple oversew of an ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG) placement is allowed.
17. Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.
18. Has donated or lost \>10% of the total blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
19. Has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug.
20. Has any screening abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the participant from entering the study; or the participant has: creatinine \>1.5 mg/dL, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 times the upper limit of normal (×ULN), or total bilirubin \>2.0 milligrams per deciliter (mg/dL) with AST/ALT elevated above the limits of normal values.
21. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study or may consent and assent (as applicable) under duress. Students of the institution/research facility who are under the supervision of, or in a subordinate role to, the investigator are also ineligible.
22. The participant, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
23. Has participated in another clinical study (not including screening for Study TAK-390MR\_205 \[NCT02615184\]) and/or has received any investigational compound within 30 days prior to Screening.
2 Years
11 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Childrens Center for Digestive Health Care, LLC
Mobile, Alabama, United States
University of Utah/ Primary Childrens Hospital
San Francisco, California, United States
Gastrointestinal Associates, PA
Centennial, Colorado, United States
Envision Clinical Research, LLC
Miami, Florida, United States
GI For Kids
Atlanta, Georgia, United States
Strada Patient Care Center, Department of Pediatric Gastroenterology
Chicago, Illinois, United States
Childrens Hospital of The Kings Daughters
Jackson, Mississippi, United States
Maspons Pediatric Gastro
Manchester, New Hampshire, United States
The University of Chicago
Cleveland, Ohio, United States
Dartmouth-Hitchcock Manchester
Oklahoma City, Oklahoma, United States
University of California San Francisco
Oklahoma City, Oklahoma, United States
c/o Chelsea Campbell, RN
Knoxville, Tennessee, United States
Vanderbilt University Medical Center,
Nashville, Tennessee, United States
Oklahoma Pediatric Digestive Institute
El Paso, Texas, United States
University Hospitals Cleveland Medical Center
Laredo, Texas, United States
IMMUNOe Research Centers
Salt Lake City, Utah, United States
National Research Centers
Norfolk, Virginia, United States
Women and Children's Health Research Institute
Edmonton, Alberta, Canada
London Health Sciences Centre Children's Hospital
London, Ontario, Canada
Hospital Universitario San Ignacio
Bogotá, , Colombia
Fundacion Valle del Lili
Cali, , Colombia
Centro Medico Imbanaco de Cali S.A
Cali, , Colombia
Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Public Institution
Kaunas, LT, Lithuania
Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, LT, Lithuania
InspirePharma S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico
Boca Clinical Trials Mexico S.C.
Querétaro, Putumayo, Mexico
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, Mexico
El Cielo Medical Center
Puebla City, , Mexico
SMIQ, S. DE R.L. DE C.V. Queretaro
Querétaro, , Mexico
Gabinet Lekarski Bartosz Korczowski
Rzeszów, PL, Poland
In Vivo Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka", Oddzial Gastroenterologii, Hepatologii, Zaburzen odzywiania i Pediatrii
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im.Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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To obtain more information on this study, click this link.
Other Identifiers
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2022-501349-64-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1166-8748
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-390MR_204
Identifier Type: -
Identifier Source: org_study_id
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