A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old

Stopped early · Phase 2

Conditions studied: Erosive Esophagitis

In brief

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. Sometimes GERD damages the lining of the esophagus, creating breaks. This is called erosive esophagitis (EE). Dexlansoprazole is a type of medicine that helps lower the amount of acid made in the stomach. It has been shown to heal EE and maintain (keep) healing of EE in adults and teenagers. This study is being done to find out if dexlansoprazole can also heal EE and maintain the healing of EE in children.

Key facts

Study ID

NCT02615184

Run by

Takeda

People needed

24

Starts

2023-05-23

Expected to finish

2026-04-13

Last updated by the study team

2026-05-06

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In the opinion of the investigator, the participant (as age appropriate) and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
• Prior to any study-specific procedures being performed, the appropriate screening informed consent and the assent forms (as applicable) must be signed and dated by parent(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 as hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive days during the Screening Period. (Note: If an endoscopy performed within 1 week of signing screening informed consent and assent [as applicable] is used to confirm diagnosis of EE, the participant does not need to meet this criterion).
• Has endoscopic evidence of EE with Los Angeles (LA) Grade A to D based on the screening endoscopy performed either during the Screening Period or within 1 week prior to signing screening informed consent and assent (as applicable). An endoscopy that was performed within 1 week prior to signing screening informed consent and assent, as applicable, is an acceptable replacement for the Screening endoscopy if EE 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 screening informed consent.

You may not qualify if…

• Has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin rash that suggests any uncontrolled, clinically significant underlying disease or condition (other than the disease being studied), which may impact the ability of the 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 of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
• 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.
• Has a history of hypersensitivity or allergies to dexlansoprazole or any component of 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 participant will require treatment with at least 1 of the disallowed concomitant medications during 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 findings suggestive 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 >4 weeks prior to Day -1, ulcers must not be present upon screening endoscopy.
• 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.
• 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 other hypersecretory condition.
• 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.
• 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 has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
• Has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug.
• 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 milligrams per deciliter (mg/dL), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevated above the limits of normal values.
• 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 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.
• The participant, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
• Has participated in another clinical study (not including screening for Study TAK-390MR_204 [NCT02616302]) and/or has received any investigational compound within 30 days prior to Screening.
• Tests positive for Helicobacter pylori.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of California San Francisco — San Francisco, California, United States
• D&H National Research Centers — Miami, Florida, United States
• Children's Center for Digestive Health Care, LLC — Atlanta, Georgia, United States
• Gastrointestinal Associates, PA — Flowood, Mississippi, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Measurable Outcome Research — Oklahoma City, Oklahoma, United States
• GI for Kids — Knoxville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Envision Clinical Research, LLC — Laredo, Texas, United States
• The Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
• Women and Children's Health Research Institute — Edmonton, Alberta, Canada
• London Health Sciences Centre (LHSC) - 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
• Boca Clinical Trials Mexico SC — Colonia Las Americas, Mexico City, Mexico
• Inspirepharma S. de R.L. de C.V. — Monterrey, Nuevo León, 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. — Querétaro, Mexico
• In Vivo Osrodek Badan Klinicznych — Bydgoszcz, Kuyavia, Poland
• Uniwersytecki Szpital Dzieciecy w Krakowie — Krakow, Lesser Poland Voivodeship, Poland
• Instytut "Pomnik - Centrum Zdrowia Dziecka" — Warsaw, Masovia, Poland
• Gabinet Lekarski Bartosz Korczowski — Rzeszów, Podkarpackie Voivodeship, Poland

Full record on ClinicalTrials.gov

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