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

NCT02615184 | Terminated Phase 2 FDA Drug

• 3 other identifiers: TAK-390MR_2052022-501350-11-00U1111-1166-8811
• Study Type: interventional
• Target: 24
• Locations: 5 countries
• Sites: 25

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. 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.

Conditions

Erosive Esophagitis

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Healing of EE by Week 8

  Healing of EE will be assessed by endoscopy.

  Week 8

• Percentage of Participants who Maintained Healed EE from Week 8 to Week 24

  Percentage of participants who maintained healed EE from Week 8 to Week 24 among the participants who were healed at Week 8 as assessed by endoscopy.

  Week 8 to Week 24

Secondary Outcomes (2)

• Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the First 8 Weeks of Treatment

  Week 8

• Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over Weeks 8 to 24 Among Participants Who were Healed by Week 8

  Weeks 8 to 24

Study Arms (4)

Healing Period: Dexlansoprazole 60 mg

EXPERIMENTAL

Dexlansoprazole 60 mg, capsules, orally, once, daily, for 8 weeks.

Drug: Dexlansoprazole

Healing Period: Dexlansoprazole 30 mg

EXPERIMENTAL

Dexlansoprazole 30 mg, capsules, orally, once, daily, for 8 weeks.

Drug: Dexlansoprazole

Maintenance of Healed EE: Dexlansoprazole 30 mg

EXPERIMENTAL

Participants on Dexlansoprazole 60 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 30 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.

Drug: Dexlansoprazole

Maintenance of Healed EE: Dexlansoprazole 15 mg

EXPERIMENTAL

Participants on Dexlansoprazole 30 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 15 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dexlansoprazole capsules

Also known as: Dexilant

Healing Period: Dexlansoprazole 30 mg; Healing Period: Dexlansoprazole 60 mg; Maintenance of Healed EE: Dexlansoprazole 15 mg; Maintenance of Healed EE: 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) 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (25)

University of South Alabama

Mobile, Alabama, 36604, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

D&H National Research Centers

Miami, Florida, 33155, United States

Location

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, 30342, United States

Location

Gastrointestinal Associates, PA

Flowood, Mississippi, 39232, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Measurable Outcome Research

Oklahoma City, Oklahoma, 73112, United States

Location

GI for Kids

Knoxville, Tennessee, 37922, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Envision Clinical Research, LLC

Laredo, Texas, 78041, United States

Location

The Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Women and Children's Health Research Institute

Edmonton, Alberta, T6G 1C9, Canada

Location

London Health Sciences Centre (LHSC) - Children's Hospital

London, Ontario, N6A 5W9, Canada

Location

Hospital Universitario San Ignacio

Bogotá, 110231, Colombia

Location

Fundacion Valle del Lili

Cali, 760032, Colombia

Location

Centro Medico Imbanaco de Cali S.A

Cali, 760042, Colombia

Location

Boca Clinical Trials Mexico SC

Colonia Las Americas, Mexico City, 1120, Mexico

Location

Inspirepharma S. de R.L. de C.V.

Monterrey, Nuevo León, 64660, Mexico

Location

Clinical Research Institute S.C.

Tlalnepantla, State of Mexico, 54055, Mexico

Location

El Cielo Medical Center

Puebla City, 72160, Mexico

Location

SMIQ S. de R.L. de C.V.

Querétaro, 76070, Mexico

Location

In Vivo Osrodek Badan Klinicznych

Bydgoszcz, Kuyavia, 85-048, Poland

Location

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Lesser Poland Voivodeship, 30-663, Poland

Location

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, Masovia, 04-730, Poland

Location

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
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MeSH Terms

Interventions

Dexlansoprazole

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

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: May 23, 2023
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

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); PL (4); CO (3); US (11); ME (5)