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

NCT02616302 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: TAK-390MR_2042022-501349-64-00U1111-1166-8748
• Study Type: interventional
• Target: 70
• Locations: 6 countries
• Sites: 33

Brief Summary

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

Gastroesophageal Reflux Disease (GERD)

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the 12 Weeks of Treatment

  Daily electronic diaries (eDiaries) will be completed which contain Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD) questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.

  Up to 12 weeks

Secondary Outcomes (6)

• Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat in Children Aged 9 to 11 Years Over the 12 Weeks of Treatment

  Up to 12 weeks

• Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat in Children Aged 2 to 8 Years Over the 12 Weeks of Treatment

  Up to 12 weeks

• Percentage of Days Without Vomiting Over the 12 Weeks of Treatment

  Up to 12 weeks

• Percentage of Days Food Did Not Come Up from Stomach to Mouth Over the 12 Weeks of Treatment

  Up to 12 weeks

• Percentage of Days Without Trouble Eating Over the 12 Weeks of Treatment

  Up to 12 weeks

Study Arms (4)

Weight ≤30 kg: Dexlansoprazole 15 mg

EXPERIMENTAL

Dexlansoprazole 15 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg.

Drug: Dexlansoprazole

Weight ≤30 kg: Dexlansoprazole 30 mg

EXPERIMENTAL

Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg.

Drug: Dexlansoprazole

Weight >30 kg: Dexlansoprazole 30 mg

EXPERIMENTAL

Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh \>30 kg.

Drug: Dexlansoprazole

Weight >30 kg: Dexlansoprazole 60 mg

EXPERIMENTAL

Dexlansoprazole 60 mg, capsules, once, daily, for 12 weeks. Participants weigh \>30 kg.

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules

Also known as: Dexilant

Weight >30 kg: Dexlansoprazole 30 mg; Weight >30 kg: Dexlansoprazole 60 mg; Weight ≤30 kg: Dexlansoprazole 15 mg; Weight ≤30 kg: Dexlansoprazole 30 mg

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• In the opinion of the investigator, the participant (as age appropriate) and/or parent(s)/legal guardian is capable of understanding and complying with protocol requirements.
• 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.
• 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.
• 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.
• 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 the formulation of dexlansoprazole capsules, or any proton pump inhibitor (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 esophagus 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 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 historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.

Sponsors & Collaborators

• Takeda: lead

Study Sites (33)

Childrens Center for Digestive Health Care, LLC

Mobile, Alabama, 36604, United States

RECRUITING

University of Utah/ Primary Childrens Hospital

San Francisco, California, 94158, United States

RECRUITING

Gastrointestinal Associates, PA

Centennial, Colorado, 80112, United States

WITHDRAWN

Envision Clinical Research, LLC

Miami, Florida, 33155, United States

WITHDRAWN

GI For Kids

Atlanta, Georgia, 30342, United States

RECRUITING

Strada Patient Care Center, Department of Pediatric Gastroenterology

Chicago, Illinois, 60637, United States

WITHDRAWN

Childrens Hospital of The Kings Daughters

Jackson, Mississippi, 39232, United States

RECRUITING

Maspons Pediatric Gastro

Manchester, New Hampshire, 79902, United States

WITHDRAWN

The University of Chicago

Cleveland, Ohio, 44106, United States

RECRUITING

Dartmouth-Hitchcock Manchester

Oklahoma City, Oklahoma, 73104, United States

WITHDRAWN

University of California San Francisco

Oklahoma City, Oklahoma, 73112, United States

WITHDRAWN

c/o Chelsea Campbell, RN

Knoxville, Tennessee, 37922, United States

WITHDRAWN

Vanderbilt University Medical Center,

Nashville, Tennessee, 37212, United States

WITHDRAWN

Oklahoma Pediatric Digestive Institute

El Paso, Texas, 79902, United States

WITHDRAWN

University Hospitals Cleveland Medical Center

Laredo, Texas, 78041, United States

WITHDRAWN

IMMUNOe Research Centers

Salt Lake City, Utah, 84113, United States

WITHDRAWN

National Research Centers

Norfolk, Virginia, 23507, United States

RECRUITING

Women and Children's Health Research Institute

Edmonton, Alberta, T6G 1C9, Canada

RECRUITING

London Health Sciences Centre Children's Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Hospital Universitario San Ignacio

Bogotá, 110231, Colombia

RECRUITING

Fundacion Valle del Lili

Cali, 760032, Colombia

RECRUITING

Centro Medico Imbanaco de Cali S.A

Cali, 760042, Colombia

RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Public Institution

Kaunas, LT, LT-50161, Lithuania

WITHDRAWN

Vilnius University Hospital Santaros Klinikos, Public Institution

Vilnius, LT, LT-08406, Lithuania

WITHDRAWN

InspirePharma S. de R.L. de C.V.

Monterrey, Nuevo León, 64660, Mexico

WITHDRAWN

Boca Clinical Trials Mexico S.C.

Querétaro, Putumayo, 1120, Mexico

RECRUITING

Clinical Research Institute S.C.

Tlalnepantla, State of Mexico, 54055, Mexico

RECRUITING

El Cielo Medical Center

Puebla City, 72160, Mexico

RECRUITING

SMIQ, S. DE R.L. DE C.V. Queretaro

Querétaro, 76070, Mexico

RECRUITING

Gabinet Lekarski Bartosz Korczowski

Rzeszów, PL, 35-302, Poland

ACTIVE NOT RECRUITING

In Vivo Osrodek Badan Klinicznych

Bydgoszcz, 85-048, Poland

ACTIVE NOT RECRUITING

Instytut "Pomnik - Centrum Zdrowia Dziecka", Oddzial Gastroenterologii, Hepatologii, Zaburzen odzywiania i Pediatrii

Warsaw, 04-730, Poland

ACTIVE NOT RECRUITING

Uniwersytecki Szpital Kliniczny im.Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-369, Poland

WITHDRAWN

Related Links

• To obtain more information on this study, click this link.

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: February 20, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CA (2); LI (2); ME (5); PL (4); US (17); CO (3)