Gastroesophageal Reflux Disease (GERD)Phase 2NCT02616302
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
A Phase 2 study testing Dexlansoprazole in people with Gastroesophageal Reflux Disease (GERD), run by Takeda at 18 sites in 5 countries.
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
- Gastroesophageal Reflux Disease (GERD)
- 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
- 71 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 20 Feb 2023to 21 Jul 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)/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.
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 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.
Show all 23Show fewer
- 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.
- 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 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.
- 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.
- 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_205 [NCT02615184]) and/or has received any investigational compound within 30 days prior to Screening.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States6 sites
GI For Kids
Atlanta, Georgia, 30342
The University of Chicago
Cleveland, Ohio, 44106
Childrens Hospital of The Kings Daughters
Jackson, Mississippi, 39232
Childrens Center for Digestive Health Care, LLC
Mobile, Alabama, 36604
National Research Centers
Norfolk, Virginia, 23507
University of Utah/ Primary Childrens Hospital
San Francisco, California, 94158
Mexico4 sites
El Cielo Medical Center
Puebla City, 72160
Boca Clinical Trials Mexico S.C.
Querétaro, Putumayo, 1120
SMIQ, S. DE R.L. DE C.V. Queretaro
Querétaro, 76070
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, 54055
Colombia3 sites
Hospital Universitario San Ignacio
Bogotá, 110231
Fundacion Valle del Lili
Cali, 760032
Centro Medico Imbanaco de Cali S.A
Cali, 760042
Poland3 sites
In Vivo Osrodek Badan Klinicznych
Bydgoszcz, 85-048
Gabinet Lekarski Bartosz Korczowski
Rzeszów, PL, 35-302
Instytut "Pomnik - Centrum Zdrowia Dziecka", Oddzial Gastroenterologii, Hepatologii, Zaburzen odzywiania i Pediatrii
Warsaw, 04-730
Canada2 sites
Women and Children's Health Research Institute
Edmonton, Alberta, T6G 1C9
London Health Sciences Centre Children's Hospital
London, Ontario, N6A 5W9
About this study
Official title: A Phase 2, Double-Blind, 12-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules in Pediatric Subjects Aged 2 to 11 Years With Symptomatic Nonerosive Gastroesophageal Reflux Disease
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.
Read the detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat children aged 2 to 11 years who have nonerosive GERD. This study will look at the effectiveness and side effects of three different doses of dexlansoprazole in children with GERD.
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
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Dexlansoprazole
- Keywords
- Drug therapy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexlansoprazoleDrug
Also called Dexilant
Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Weight ≤30 kg: Dexlansoprazole 15 mg | Experimental | Dexlansoprazole 15 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg. Receives: Drug: Dexlansoprazole |
| Weight ≤30 kg: Dexlansoprazole 30 mg | Experimental | Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg. Receives: Drug: Dexlansoprazole |
| Weight >30 kg: Dexlansoprazole 30 mg | Experimental | Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh >30 kg. Receives: Drug: Dexlansoprazole |
| Weight >30 kg: Dexlansoprazole 60 mg | Experimental | Dexlansoprazole 60 mg, capsules, once, daily, for 12 weeks. Participants weigh >30 kg. Receives: Drug: Dexlansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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: 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
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: Up to 12 weeks
Percentage of Days Without Vomiting Over the 12 Weeks of Treatment
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: Up to 12 weeks
Percentage of Days Food Did Not Come Up from Stomach to Mouth Over the 12 Weeks of Treatment
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: Up to 12 weeks
Percentage of Days Without Trouble Eating Over the 12 Weeks of Treatment
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: Up to 12 weeks
Difference of the Median Percentage of Days Without Hurting or Burning in the Stomach, Chest, or Throat Over the 12 Weeks of Treatment Between the High Dose and the low Dose Within Each Weight Strata
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: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start20 Feb 2023
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616302
- Sponsor's protocol ID
- TAK-390MR_204
- Other IDs
- 2022-501349-64-00, U1111-1166-8748
- Status last verified
- Jul 2026
- First submitted
- 24 Nov 2015
- Last updated
- 29 Jul 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, 12-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules in Pediatric Subjects Aged 2 to 11 Years With Symptomatic Nonerosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT02616302
- Acronym / sponsor ID
- TAK-390MR_204
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat children aged 2 to 11 years who have nonerosive GERD. This study will look at the effectiveness and side effects of three different doses of dexlansoprazole in children with GERD.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Weight ≤30 kg: Dexlansoprazole 15 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 15 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg. |
| Weight ≤30 kg: Dexlansoprazole 30 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg. |
| Weight >30 kg: Dexlansoprazole 30 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh >30 kg. |
| Weight >30 kg: Dexlansoprazole 60 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 60 mg, capsules, once, daily, for 12 weeks. Participants weigh >30 kg. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexlansoprazoleAlso: DexilantDexlansoprazole 15 mg, 30 mg, and 60 mg capsules | Drug | Weight >30 kg: Dexlansoprazole 30 mg, Weight >30 kg: Dexlansoprazole 60 mg, Weight ≤30 kg: Dexlansoprazole 15 mg, Weight ≤30 kg: Dexlansoprazole 30 mg |
Primary outcome
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the 12 Weeks of Treatment
Time frame: Up to 12 weeks
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.
6 secondary outcomes
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
Time frame: 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
Time frame: Up to 12 weeks
Percentage of Days Without Vomiting Over the 12 Weeks of Treatment
Time frame: Up to 12 weeks
Percentage of Days Food Did Not Come Up from Stomach to Mouth Over the 12 Weeks of Treatment
Time frame: Up to 12 weeks
Percentage of Days Without Trouble Eating Over the 12 Weeks of Treatment
Time frame: Up to 12 weeks
Difference of the Median Percentage of Days Without Hurting or Burning in the Stomach, Chest, or Throat Over the 12 Weeks of Treatment Between the High Dose and the low Dose Within Each Weight Strata
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- 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.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexlansoprazole in people with Gastroesophageal Reflux Disease (GERD), run by Takeda at 18 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 23 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: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Mexico, Colombia, Poland, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Days Without Hurting or Burning in the Stomach, Chest or Throat Over the 12 Weeks of Treatment (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2026.