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CompletedNCT00847210Updated Feb 2, 2012Results posted

Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease

A Phase 1 interventional study of Dexlansoprazole MR and Dexlansoprazole MR in Gastroesophageal Reflux, sponsored by Takeda. Completed at 3 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2012-02-02.

Sponsored by Takeda · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.

Read the detailed description

Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chronic disease that can persist through adulthood with symptoms in older children and adolescents being similar to those seen in adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17 years.

Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal inflammation.

This study evaluated the pharmacokinetics and safety of dexlansoprazole MR in the pediatric population (ages 12-17) and determined if the pharmacokinetic profile is similar to that in adults given the same dose.

02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • Esophageal Reflux
  • Gastro-Esophageal Reflux
  • Gastroesophageal Reflux Disease
  • GERD
  • Regurgitation, Gastric
  • Heartburn
  • Drug Therapy
  • Adolescent
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 36 is below the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body weight is greater than or equal to 30 kg.
  • Females of childbearing potential who are sexually active must agree to use an acceptable form of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Must have an estimated creatinine clearance greater than or equal to 80 mL/minute as determined from the Cockcroft-Gault formula.
  • Participants who take prescription or non-prescription proton pump inhibitors, histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage throughout the study.
  • Must have a history of gastroesophageal reflux disease symptoms, as documented by a physician, for at least 2 months prior to Screening or is currently symptomatic.
  • Must be able to swallow study drug capsule or must be able to ingest study drug granules sprinkled on 1 tablespoon of applesauce.

Exclusion criteria

Exclusion Criteria:

  • Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
  • 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 trial or that would contraindicate taking dexlansoprazole MR or a similar drug in the same class.
  • Has a known hypersensitivity to any proton pump inhibitors or any component of the formulation of dexlansoprazole MR (see most current version of the Investigator Brochures).
  • Has a history of malignant disease.
  • Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody.
  • Has a known history of infection with the human immunodeficiency virus.
  • Has donated or lost greater than or equal to 300 mL blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
  • Is required to take or intends to continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
  • Has consumed grapefruit or grapefruit juice within 14 days prior to the first dose of study drug or is unwilling to agree to abstain from grapefruit or grapefruit juice while participating in the study.
  • Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  • Has used a product containing nicotine within 90 days prior to the first dose of study drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is unwilling to agree to abstain throughout the study.
  • Has participated in a study of an investigational agent (including dosing or follow up) within 30 days prior to first dose of study drug.
  • Has an initial Screening Visit or Day -1 laboratory value that the principal investigator considers to be clinically significant.
  • Participant is determined to be a CYP2C19 isozyme poor metabolizer (ie, genotyped homozygous non-wild type).
  • Is unlikely to comply with the protocol or is unsuitable for any other reason per the opinion of the investigator
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Dexlansoprazole MR 30 mg QD

    Drug: Dexlansoprazole MR

  • Experimental
    Dexlansoprazole MR 60 mg QD

    Drug: Dexlansoprazole MR

Interventions

  • DrugDexlansoprazole MR

    Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.

    Also known as: TAK-390MR, Kapidex, Dexilant

  • DrugDexlansoprazole MR

    Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.

    Also known as: TAK-390MR, Kapidex, Dexilant

06

What researchers measure

Primary outcomes

  1. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

    Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.

    Time frame: After 7 days of dosing.

  2. Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.

    Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

    Time frame: After 7 days of dosing.

  3. AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.

    Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).

    Time frame: After 7 days of dosing.

  4. AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.

    AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval - 24 hours in this study).

    Time frame: After 7 days of dosing.

  5. Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.

    Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

    Time frame: After 7 days of dosing.

  6. Oral Clearance (CL/F) Pharmacokinetic Parameter.

    CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.

    Time frame: After 7 days of dosing.

  7. Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.

    Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.

    Time frame: After 7 days of dosing.

  8. Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.

    Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.

    Time frame: After 7 days of dosing.

07

Results

Posted Oct 5, 2010
Limitations and caveats
For outcome measures #4, 5, 6, 7 and 8, outcomes could not be estimated for one participant in the 30 mg dose group.

Participant flow

Participants were enrolled at 3 investigative sites in the United States from 31 May 2009 to 10 September 2009.

Participant flow — Overall Study
MilestoneDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Started1818
Completed1818
Not completed00

Outcome measures

PrimaryTmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.

Time frame:
After 7 days of dosing.
Reported as:
Mean · hours
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
hoursDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter4.65 ± 2.9093.31 ± 1.519
Statistical analysis
  • Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD · ANOVA · p = 0.095 (There was no statistical significant difference (p-value \>0.05) in Tmax between the 30 mg and 60 mg dose group. Both age group and site did not have statistically significant effects on Tmax.)
PrimaryCmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.

Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

Time frame:
After 7 days of dosing.
Reported as:
Mean · ng/mL
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.
ng/mLDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.691 ± 367.51136 ± 582.2
Statistical analysis
  • Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD · ANOVA · p = 0.289 · Ratio of the central values for cmax: 1.210 · 90% CI 0.897 to 1.630Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole pharmacokinetics between regimens were computed based on the frame work of ANOVA.
PrimaryAUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.

Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).

Time frame:
After 7 days of dosing.
Reported as:
Mean · ng*hr/mL/mg
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.
ng*hr/mL/mgDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.2842.32 ± 1313.8275113.72 ± 2987.508
Statistical analysis
  • Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD · ANOVA · p = 0.402 · Ratio of the dose-normalized auc(0-tlqc): 1.158 · 90% CI 0.864 to 1.551Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-tlqc) between regimens were computed based on the frame work of ANOVA.
PrimaryAUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.

AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval - 24 hours in this study).

Time frame:
After 7 days of dosing.
Reported as:
Mean · ng*hr/mL/mg
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.
ng*hr/mL/mgDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.2886.26 ± 1355.1825119.81 ± 2986.453
Statistical analysis
  • Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD · ANOVA · p = 0.388 · Ratio of the central values for dose-nor: 1.168 · 90% CI 0.864 to 1.579Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-24) between regimens were computed based on the frame work of ANOVA.
PrimaryTerminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.

Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

Time frame:
After 7 days of dosing.
Reported as:
Mean · hours
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.
hoursDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.1.66 ± 0.8712.59 ± 1.379
PrimaryOral Clearance (CL/F) Pharmacokinetic Parameter.

CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.

Time frame:
After 7 days of dosing.
Reported as:
Mean · liter/hr
Oral Clearance (CL/F) Pharmacokinetic Parameter.
liter/hrDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Oral Clearance (CL/F) Pharmacokinetic Parameter.12.81 ± 6.09215.29 ± 7.524
PrimaryTerminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.

Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.

Time frame:
After 7 days of dosing.
Reported as:
Mean · 1/hr
Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.
1/hrDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.0.5264 ± 0.254250.3404 ± 0.17406
PrimaryApparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.

Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.

Time frame:
After 7 days of dosing.
Reported as:
Mean · L
Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.
LDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.28.90 ± 21.20858.50 ± 46.100

Adverse events

Collected over Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dexlansoprazole MR 30 mg QD—0/18 (0%)7/18 (38.9%)
Dexlansoprazole MR 60 mg QD—0/18 (0%)5/18 (27.8%)
Most frequent other events
Most frequent other events
EventDexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QD
Abdominal PainGastrointestinal disorders4/180/18
VomitingGastrointestinal disorders0/182/18
HeadacheNervous system disorders1/182/18
DyspepsiaGastrointestinal disorders0/181/18
EructationGastrointestinal disorders0/181/18
Feelings of Body Temperature ChangeGeneral disorders0/181/18
ContusionInjury, poisoning and procedural complications0/181/18
DizzinessNervous system disorders1/181/18
PresyncopeNervous system disorders1/181/18
RashSkin and subcutaneous tissue disorders1/180/18

Baseline characteristics

Age Continuous
Age Continuous(years)Dexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QDTotal
Mean14.6 ± 1.6514.6 ± 1.8914.6 ± 1.75
Sex: Female, Male
Sex: Female, Male(Participants)Dexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QDTotal
Female111122
Male7714
Region of Enrollment
Region of Enrollment(participants)Dexlansoprazole MR 30 mg QDDexlansoprazole MR 60 mg QDTotal
United States181836
08

Study locations

3 sites
  • Anaheim, California, United States
  • Cypress, California, United States
  • Overland Park, Kansas, United States
09

References and documents

Publications

  • Kukulka M, Wu J, Perez MC. Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic GERD. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):41-7. doi: 10.1097/MPG.0b013e31822a323a. PubMed 21716130 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00847210
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Feb 19, 2009
Start date
May 2009
Primary completion
Sep 2009
Completion
Sep 2009
Results posted
Oct 5, 2010
Last update
Feb 2, 2012

Study contacts

Medical Director Pharmacovigilance
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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