Pediatric Gastroesophageal Reflux DiseasePhase 1NCT02442752
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
A Phase 1 study testing Dexlansoprazole in people with Pediatric Gastroesophageal Reflux Disease, run by Takeda at 22 sites in 5 countries.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases. Read more about this study
- Who is it for?
- Ages 1 month to 11 months
- Conditions the study is for
- Pediatric Gastroesophageal Reflux Disease
- 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
- 0 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 15 Jun 2025to 23 Dec 2025
- Phase
- Phase 1
- 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 1 month to 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prior to any study-specific procedures being performed and after having the study fully explained and all questions answered, the informed consent form (ICF) must be signed and dated by parent(s) or legal guardian(s). The Screening Period starts at the time of consent.
- Is a male or female infant 1 to 11 months old, inclusive, on Day 1. Infants who were born prematurely must be ≥ 45 weeks old based on corrected gestational age.
- At the Initial Screening and Day -1 visits, participant must have body weight percentile-for-age within the 5th through 95th percentile by age, inclusive, as determined by the World Health Organization (WHO) growth chart.
- Must be ≥ 3.4 kg at the Screening and Day -1 visits.
- Participants who take a prescription or nonprescription proton pump inhibitor (PPI), histamine-2 receptor antagonists(H2RA), sucralfate, or antacids on a regular or as required basis must agree to discontinue use at Day -1 (except cimetidine, which must be discontinued 28 days prior to Day -1) or other acid suppression therapy, and agree to discontinue use throughout the study.
- Must have endoscopically proven erosive esophagitis (EE), a history of EE, and/or 1 or more of the following underlying conditions that predispose the participant to chronic gastroesophageal reflux disease (GERD) and EE: moderate to severe neurologic impairment, repaired esophageal atresia, hiatal hernia, cystic fibrosis, bronchopulmonary dysplasia, or end-stage renal disease.
Show all 12Show fewer
- Except for participants with EE, a history of EE, or repaired esophageal atresia, participants have:
- Received prior PPI therapy or other acid suppression therapy for a minimum of 2 weeks during any time in the past with symptomatic response and have demonstrated a recurrence of symptoms following at least 1 attempted withdrawal of PPI therapy or other acid suppression therapy AND
- Have undergone esophageal pH monitoring in the recent past to document that their symptoms are due to acid-mediated disease.
- Must be able to ingest study medication granules sprinkled on 1 tablespoon of applesauce or pureed apples, or as a mixture of granules in water administered via an oral syringe.
- Must be at least 7 days post-surgery by dosing on Day 1 and have no anticipated need for surgery during the study.
- Screening laboratory samples must be collected Day -7 to Day -2) and the results must be within the range expected for this infant population (except gastrin results as those results will be available after Day 1). The laboratory results should indicate no clinically significant (CS) abnormality in chemistry (including electrolytes, blood urea nitrogen [BUN]), creatinine, glucose, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin), hematology (complete blood cell count, including differential), and urinalysis parameters (if standard of care).
Who cannot join
- Has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests clinically significant, uncontrolled underlying disease or condition (other than the disease being studied and/or identified as the main criterion for inclusion), that may impact the ability of the participant to participate or potentially may confound the study results.
- Has known history of or current presence of peptic ulcers or gastrointestinal bleeding (hematemesis, hematochezia).
- Has poor venous access or any contraindication to blood sampling.
- Has known history of eosinophilic gastroenteropathy, or a coexisting disease affecting the esophagus, including esophageal varices, viral or fungal infection, or esophageal stricture, history of radiation therapy or cryotherapy to the esophagus, and caustic or physiochemical trauma such as sclerotherapy to the esophagus.
- Has active malabsorption syndrome, cow's milk intolerance, milk protein allergy, or celiac disease.
- Has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of a disease that might interfere with the conduct of the study or that would contraindicate taking dexlansoprazole delayed-release capsules or a similar drug in the same class (ie, a PPI).
Show all 22Show fewer
- Has a known hypersensitivity to any PPI or any component of the formulation of dexlansoprazole delayed-release capsules.
- 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 history of malignant disease.
- Has a known history of infection with the human immunodeficiency virus.
- Has 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 medication.
- Has consumed Excluded Medications and Dietary Products during the time periods listed, or parent(s) or legal guardian(s) is unwilling to agree to participant abstaining from products while participating in the study.
- Has participated in a study of an investigational agent (including dosing or follow-up) within 30 days prior to Screening.
- Has a Screening Visit laboratory value that the principal investigator and sponsor consider to be clinically significant.
- Has creatinine > 1.5 mg/dL, ALT and/or 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.
- The participant or parent/legal guardian 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 under duress.
- Parent/legal guardian, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
- Has any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, pH, or absorption, or has an active or known history of necrotizing enterocolitis that has been surgically corrected.
- Has clinical evidence of acute sepsis. Infants on chronic antibiotics who are otherwise clinically stable may be enrolled in the study at the discretion of the investigator.
- Has received a vaccine within 48 hours prior to dosing on Day 1.
- Has used intravenous or oral antifungal agents within the 7 days prior to Day -1.
- Has used mucosal protective agent (eg, sucralfate) within 6 hours prior to dosing on Day 1.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
United States6 sites
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21218
Michigan Pediatric GI Center
Flint, Michigan, 48532
Cook Children's Medical Center
Fort Worth, Texas, 76104
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Louisville
Louisville, Kentucky, 40202
Promedica Toledo Children's Hospital
Toledo, Ohio, 43606
Poland5 sites
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 85-168
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, 30-663
Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, 20-093
Szpital Wojewodzki nr 2 w Rzeszowie
Rzeszów, 35-301
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-730
Israel4 sites
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
Schneider Children's Medical Center
Petah Tikva, 4920235
Sheba Medical Center
Ramat Gan, 5262000
Assaf Harofeh M.C
Rishon LeZiyyon, 75309
Italy4 sites
Azienda Ospedaliera Universitaria "Federico II"
Naples, 80131
Umberto I Pol. di Roma-Universita di Roma La Sapienza
Roma, 00161
Ospedale Pediatrico Bambino Gesu
Roma, 00165
Policlinico Universitario Agostino Gemelli
Roma, 00168
Mexico3 sites
Centro de Investigacion Clinica Acelerada, S.C.
Mexico City, Mexico City, 07020
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León, 64000
Centro de Investigacion Clinica Chapultepec S.A. de C.V.
Morelia, Michoacán, 58260
About this study
Official title: A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.
Read the detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to find a safe and well-tolerated dose and to assess how dexlansoprazole is processed by the body in infants aged 1 to 11 months. This study will look at side effects and lab results in infants who take dexlansoprazole.
The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 4 treatment groups based on body weight and age:
- Dexlansoprazole 10 mg
- Dexlansoprazole 15 mg
- Dexlansoprazole 20 mg
- Dexlansoprazole 30 mg
Participants who weigh <3.4 kg will not be enrolled. Participants ≤ 10 weeks of age with a body weight of ≥ 3.4 kg will initially receive Regimen A (dexlansoprazole delayed-release 10 mg capsules). Randomization for participants > 10 weeks of age will be stratified by weight group. Participants whose baseline weight is ≥ 3.4 kg but < 4.1 kg will be assigned to receive Regimen A or Regimen B (dexlansoprazole delayed-release 10 or 15 mg capsules as an initial dose) in a ratio of 1:1. Participants whose weight is ≥ 4.1 kg but < 6.2 kg will be assigned to receive Regimens B or C (dexlansoprazole delayed-release 15 or 20 mg capsules as an initial dose) in a ratio of 1:1. Participants whose weight is ≥ 6.2 kg will be assigned to receive Regimen B, C, or D (dexlansoprazole delayed-release 15, 20, or 30 mg capsules as an initial dose) in a ratio of 1:1:2.
All participants will be administered 1 capsule of dexlansoprazole in the morning at the same time each day throughout the study. The study medication may be administered to the participants by opening a capsule and sprinkling the granules on 1 tablespoon of applesauce or pureed apples, or mixing the capsule granules with about 20 mL of water. The food-granule mixture should be administered immediately. The water mixed with the granules will be administered via an oral syringe into the mouth immediately. The granules should not be chewed in mouth. The food or liquid used for administering the study medication should be recorded for Days 1 through Confinement Day 1. The parents of all participants will be asked to record dosing information, the food or liquid used for administering the study medication (Day 1 through Confinement Day 1), food intake, and episodes of vomiting in a diary from Day 2 until the day before Confinement Day 1 (Day 5 to 9).
This multicenter trial will be conducted worldwide. The overall time to participate in this study is up to 114 days. Participants will make multiple visits to the clinic, including two 2-day visits that may require confinement to the clinic, and will be contacted by telephone 30 days 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 TAK-390MR
Dexlansoprazole capsules
| Study group | Role | What they receive |
|---|---|---|
| Regimen A: Dexlansoprazole 10 mg | Experimental | Dexlansoprazole 10 mg, delayed-release capsules, orally, once daily for 8 weeks. Receives: Drug: Dexlansoprazole |
| Regimen B: Dexlansoprazole 15 mg | Experimental | Dexlansoprazole 15 mg, delayed-release capsules, orally, once daily for 8 weeks. Receives: Drug: Dexlansoprazole |
| Regimen C: Dexlansoprazole 20 mg | Experimental | Dexlansoprazole 20 mg, delayed-release capsules, orally, once daily for 8 weeks. Receives: Drug: Dexlansoprazole |
| Regimen D: Dexlansoprazole 30 mg | Experimental | Dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for 8 weeks. Receives: Drug: Dexlansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Dexlansoprazole
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of Dexlansoprazole
Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration.
Measured: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Area Under the Plasma Concentration-Time Curve From Time 0 to Time tau [AUCtau)] for Dexlansoprazole
Area under the plasma concentration-time curve from time 0 to time tau, where tau is the length of the dosing interval.
Measured: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Dose Normalized Maximum Observed Plasma Concentration (Cmax/dose) of Dexlansoprazole
Dose normalized maximum observed plasma concentration (Cmax/dose) is the peak plasma concentration of a drug after administration obtained directly from the plasma concentration-time curve, divided by the administered dose in milligrams.
Measured: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Dose Normalized Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt/dose) of Dexlansoprazole
Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration divided by the administered dose in milligrams.
Measured: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Dose Normalized Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt/dose) of Dexlansoprazole
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval, divided by the administered dose in milligrams.
Measured: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Change from Baseline in Percent of Time with Intragastric pH>4
Intragastric pH will be measured approximately every 2 to 4 seconds, based on the pH recorder used for the measurement, for a 24-hour period. Fifteen minute medians are calculated and the percent of time pH is greater than 4 is calculated for the 24 hour period.
Measured: Baseline and Confinement Day 1(Between Day 5 and Day 9) [up to 24 hours post-dose]
Change from Baseline in Mean 24-Hour Intragastric pH
Intragastric pH will be measured approximately every 2 to 4 seconds, based on the pH recorder used for the measurement, for a 24-hour period. Fifteen minute medians are calculated and the mean pH is calculated for the 24 hour period.
Measured: Baseline and Confinement Day 1(Between Day 5 and Day 9) [up to 24 hours post-dose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start15 Jun 2025 (estimated)
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Why it stopped: Withdrawn: Business decision (no enrollment)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Gastroesophageal Reflux DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442752
- Sponsor's protocol ID
- TAK-390MR_108
- Other IDs
- 2014-001642-16, U1111-1162-4853, 153300410A0065, 2014
- Status last verified
- Apr 2020
- First submitted
- 9 May 2015
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases
- ClinicalTrials.gov ID
- NCT02442752
- Acronym / sponsor ID
- TAK-390MR_108
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn: Business decision (no enrollment)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 13 May 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.
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.
Detailed description
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to find a safe and well-tolerated dose and to assess how dexlansoprazole is processed by the body in infants aged 1 to 11 months. This study will look at side effects and lab results in infants who take dexlansoprazole.
The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 4 treatment groups based on body weight and age:
- Dexlansoprazole 10 mg
- Dexlansoprazole 15 mg
- Dexlansoprazole 20 mg
- Dexlansoprazole 30 mg
Participants who weigh <3.4 kg will not be enrolled. Participants ≤ 10 weeks of age with a body weight of ≥ 3.4 kg will initially receive Regimen A (dexlansoprazole delayed-release 10 mg capsules). Randomization for participants > 10 weeks of age will be stratified by weight group. Participants whose baseline weight is ≥ 3.4 kg but < 4.1 kg will be assigned to receive Regimen A or Regimen B (dexlansoprazole delayed-release 10 or 15 mg capsules as an initial dose) in a ratio of 1:1. Participants whose weight is ≥ 4.1 kg but < 6.2 kg will be assigned to receive Regimens B or C (dexlansoprazole delayed-release 15 or 20 mg capsules as an initial dose) in a ratio of 1:1. Participants whose weight is ≥ 6.2 kg will be assigned to receive Regimen B, C, or D (dexlansoprazole delayed-release 15, 20, or 30 mg capsules as an initial dose) in a ratio of 1:1:2.
All participants will be administered 1 capsule of dexlansoprazole in the morning at the same time each day throughout the study. The study medication may be administered to the participants by opening a capsule and sprinkling the granules on 1 tablespoon of applesauce or pureed apples, or mixing the capsule granules with about 20 mL of water. The food-granule mixture should be administered immediately. The water mixed with the granules will be administered via an oral syringe into the mouth immediately. The granules should not be chewed in mouth. The food or liquid used for administering the study medication should be recorded for Days 1 through Confinement Day 1. The parents of all participants will be asked to record dosing information, the food or liquid used for administering the study medication (Day 1 through Confinement Day 1), food intake, and episodes of vomiting in a diary from Day 2 until the day before Confinement Day 1 (Day 5 to 9).
This multicenter trial will be conducted worldwide. The overall time to participate in this study is up to 114 days. Participants will make multiple visits to the clinic, including two 2-day visits that may require confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen A: Dexlansoprazole 10 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 10 mg, delayed-release capsules, orally, once daily for 8 weeks. |
| Regimen B: Dexlansoprazole 15 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 15 mg, delayed-release capsules, orally, once daily for 8 weeks. |
| Regimen C: Dexlansoprazole 20 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 20 mg, delayed-release capsules, orally, once daily for 8 weeks. |
| Regimen D: Dexlansoprazole 30 mg | Experimental | Drug: DexlansoprazoleDexlansoprazole 30 mg, delayed-release capsules, orally, once daily for 8 weeks. |
Who may qualify
- Ages
- 1 month to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Prior to any study-specific procedures being performed and after having the study fully explained and all questions answered, the informed consent form (ICF) must be signed and dated by parent(s) or legal guardian(s). The Screening Period starts at the time of consent.
- Is a male or female infant 1 to 11 months old, inclusive, on Day 1. Infants who were born prematurely must be ≥ 45 weeks old based on corrected gestational age.
- At the Initial Screening and Day -1 visits, participant must have body weight percentile-for-age within the 5th through 95th percentile by age, inclusive, as determined by the World Health Organization (WHO) growth chart.
- Must be ≥ 3.4 kg at the Screening and Day -1 visits.
- Participants who take a prescription or nonprescription proton pump inhibitor (PPI), histamine-2 receptor antagonists(H2RA), sucralfate, or antacids on a regular or as required basis must agree to discontinue use at Day -1 (except cimetidine, which must be discontinued 28 days prior to Day -1) or other acid suppression therapy, and agree to discontinue use throughout the study.
Key exclusion criteria (22 listed)
- Has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests clinically significant, uncontrolled underlying disease or condition (other than the disease being studied and/or identified as the main criterion for inclusion), that may impact the ability of the participant to participate or potentially may confound the study results.
- Has known history of or current presence of peptic ulcers or gastrointestinal bleeding (hematemesis, hematochezia).
- Has poor venous access or any contraindication to blood sampling.
- Has known history of eosinophilic gastroenteropathy, or a coexisting disease affecting the esophagus, including esophageal varices, viral or fungal infection, or esophageal stricture, history of radiation therapy or cryotherapy to the esophagus, and caustic or physiochemical trauma such as sclerotherapy to the esophagus.
- Has active malabsorption syndrome, cow's milk intolerance, milk protein allergy, or celiac disease.
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: TAK-390MRDexlansoprazole capsules | Drug | Regimen A: Dexlansoprazole 10 mg, Regimen B: Dexlansoprazole 15 mg, Regimen C: Dexlansoprazole 20 mg, Regimen D: Dexlansoprazole 30 mg |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Dexlansoprazole
Time frame: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt) of Dexlansoprazole
Time frame: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time tau [AUCtau)] for Dexlansoprazole
Time frame: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Area under the plasma concentration-time curve from time 0 to time tau, where tau is the length of the dosing interval.
Dose Normalized Maximum Observed Plasma Concentration (Cmax/dose) of Dexlansoprazole
Time frame: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Dose normalized maximum observed plasma concentration (Cmax/dose) is the peak plasma concentration of a drug after administration obtained directly from the plasma concentration-time curve, divided by the administered dose in milligrams.
Dose Normalized Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt/dose) of Dexlansoprazole
Time frame: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration divided by the administered dose in milligrams.
Dose Normalized Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUCt/dose) of Dexlansoprazole
Time frame: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval, divided by the administered dose in milligrams.
Change from Baseline in Percent of Time with Intragastric pH>4
Time frame: Baseline and Confinement Day 1(Between Day 5 and Day 9) [up to 24 hours post-dose]
Intragastric pH will be measured approximately every 2 to 4 seconds, based on the pH recorder used for the measurement, for a 24-hour period. Fifteen minute medians are calculated and the percent of time pH is greater than 4 is calculated for the 24 hour period.
Change from Baseline in Mean 24-Hour Intragastric pH
Time frame: Baseline and Confinement Day 1(Between Day 5 and Day 9) [up to 24 hours post-dose]
Intragastric pH will be measured approximately every 2 to 4 seconds, based on the pH recorder used for the measurement, for a 24-hour period. Fifteen minute medians are calculated and the mean pH is calculated for the 24 hour period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
Related trials for Pediatric Gastroesophageal Reflux Disease
Recruiting
Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
Laryngomalacia
Recruiting
Laparoscopic Management of Gastroesophageal Reflux Disease in Children
Gastric Function Disorder
Not yet recruitingObservational study
Intestinal Microbiota After PPI Treatment
Proton Pump Inhibitors, Human Gastrointestinal Tract
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.
Medical Director Clinical Science study director
Takeda
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexlansoprazole in people with Pediatric Gastroesophageal Reflux Disease, run by Takeda at 22 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 12 inclusion and 22 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: withdrawn, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Poland, Israel, Italy, Mexico. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
Maximum Observed Plasma Concentration (Cmax) of Dexlansoprazole (time frame: Confinement Day 1 (Between Day 5 and Day 9) Pre-dose, and at multiple timepoints (up to 12 hours) post-dose). The study lists 8 primary outcomes in all. 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 15 Apr 2020.