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Erosive EsophagitisPhase 2NCT02615184

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

A Phase 2 study testing Dexlansoprazole in people with Erosive Esophagitis, run by Takeda at 25 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
Erosive Esophagitis
What is being tested?
Dexlansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
25 sitesin 5 countries
Study dates
23 May 2023to 13 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

United States11 sites

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia, 30342

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Gastrointestinal Associates, PA

    Flowood, Mississippi, 39232

  • GI for Kids

    Knoxville, Tennessee, 37922

  • Envision Clinical Research, LLC

    Laredo, Texas, 78041

  • D&H National Research Centers

    Miami, Florida, 33155

  • University of South Alabama

    Mobile, Alabama, 36604

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • The Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

  • Measurable Outcome Research

    Oklahoma City, Oklahoma, 73112

  • University of California San Francisco

    San Francisco, California, 94158

Other trials in United States

Mexico5 sites

  • Boca Clinical Trials Mexico SC

    Colonia Las Americas, Mexico City, 1120

  • Inspirepharma S. de R.L. de C.V.

    Monterrey, Nuevo León, 64660

  • El Cielo Medical Center

    Puebla City, 72160

  • SMIQ S. de R.L. de C.V.

    Querétaro, 76070

  • Clinical Research Institute S.C.

    Tlalnepantla, State of Mexico, 54055

Other trials in Mexico

Poland4 sites

  • In Vivo Osrodek Badan Klinicznych

    Bydgoszcz, Kuyavia, 85-048

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-663

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, Podkarpackie Voivodeship, 35-302

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, Masovia, 04-730

Other trials in Poland

Colombia3 sites

  • Hospital Universitario San Ignacio

    Bogotá, 110231

  • Fundacion Valle del Lili

    Cali, 760032

  • Centro Medico Imbanaco de Cali S.A

    Cali, 760042

Other trials in Colombia

Canada2 sites

  • Women and Children's Health Research Institute

    Edmonton, Alberta, T6G 1C9

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

    London, Ontario, N6A 5W9

Other trials in Canada

About this study

Official title: A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 2 to 11 Years With EE

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.

Read the detailed description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to heal EE and maintain healing of EE in pediatric participants aged 2 to 11 years. This study will look at the healing of EE followed by maintained healing of EE in children who take dexlansoprazole.

The study will be conducted in two periods; a Healing of EE Period and a Maintenance of Healed EE Period. Approximately 76 patients will be enrolled in this study. Participants will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 60 milligrams (mg) or dexlansoprazole 30 mg for 8 weeks during the Healing of EE Period. Following Week 8, participants will enter the Maintenance of Healed EE Period and will receive half their healing dose of dexlansoprazole, (i.e., either 30 mg, dexlansoprazole 15 mg).

All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have heartburn symptoms in a diary.

Participants who complete the 16 weeks of the Maintenance of Healed EE Period (Week 24) and have maintained healing of EE as confirmed by endoscopy, will enter a Post-Treatment Follow up Period for up to 3 months after the last dose of study drug. During this period participants will continue to complete the symptom questionnaires daily in the eDiaries and return for a clinic visit each month. Participants who require an invasive procedure or treatment with a proton pump inhibitor (PPI) or histamine 2-receptor antagonist (H2RA) for gastroesophageal reflux disease (GERD)/EE will be discontinued from the Post-Treatment Follow-up Period and a Final Study Visit will be performed.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 10 months. Participants will make multiple visits to the clinic including a final visit 3 months after last dose of study drug for a follow-up assessment.

Being tested
Dexlansoprazole
Keywords
Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexlansoprazoleDrug

    Also called Dexilant

    Dexlansoprazole capsules

Study groups in NCT02615184
Study groupRoleWhat they receive
Healing Period: Dexlansoprazole 60 mgExperimentalDexlansoprazole 60 mg, capsules, orally, once, daily, for 8 weeks.
Receives: Drug: Dexlansoprazole
Healing Period: Dexlansoprazole 30 mgExperimentalDexlansoprazole 30 mg, capsules, orally, once, daily, for 8 weeks.
Receives: Drug: Dexlansoprazole
Maintenance of Healed EE: Dexlansoprazole 30 mgExperimentalParticipants 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.
Receives: Drug: Dexlansoprazole
Maintenance of Healed EE: Dexlansoprazole 15 mgExperimentalParticipants 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.
Receives: Drug: Dexlansoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Healing of EE by Week 8

    Healing of EE will be assessed by endoscopy.

    Measured: Week 8

  2. 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.

    Measured: Week 8 to Week 24

Secondary outcomes (2)

  1. Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the First 8 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.

    Measured: Week 8

  2. 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

    Daily eDiaries will be completed which contain 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.

    Measured: Weeks 8 to 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2015 (estimated)
  2. Study start23 May 2023
  3. Primary completion13 Apr 2026
  4. Study completion13 Apr 2026

Why it stopped: Study related

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02615184
Sponsor's protocol ID
TAK-390MR_205
Other IDs
2022-501350-11-00, U1111-1166-8811
Status last verified
May 2026
First submitted
24 Nov 2015
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexlansoprazole in people with Erosive Esophagitis, run by Takeda at 25 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Mexico, Poland, Colombia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study related). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Healing of EE by Week 8 (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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