Gastroesophageal RefluxPhase 1NCT00847210

Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease

A Phase 1 study testing Dexlansoprazole MR in people with Gastroesophageal Reflux, run by Takeda at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Gastroesophageal Reflux
What is being tested?: Dexlansoprazole MR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 3 sitesUnited States
Study dates: May 2009to Sep 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Anaheim, California
Study site
Cypress, California
Study site
Overland Park, Kansas

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents 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.

Conditions: Gastroesophageal Reflux
Being tested: Dexlansoprazole MR
Keywords: Esophageal Reflux, Gastro-Esophageal Reflux, Gastroesophageal Reflux Disease, GERD, Regurgitation, Gastric, Heartburn, Drug Therapy, Adolescent
Medical subject headings: Gastroesophageal Reflux, Laryngopharyngeal Reflux, Heartburn

What participants receive

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

Dexlansoprazole MRDrug
Also called TAK-390MR, Kapidex, Dexilant
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
Dexlansoprazole MRDrug
Also called TAK-390MR, Kapidex, Dexilant
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.

Study groups in NCT00847210
Study group	Role	What they receive
Dexlansoprazole MR 30 mg QD	Experimental	Not described Receives: Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg QD	Experimental	Not described Receives: Drug: Dexlansoprazole MR

What is being measured

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

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.
Measured: After 7 days of dosing.
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.
Measured: After 7 days of dosing.
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]).
Measured: After 7 days of dosing.
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).
Measured: After 7 days of dosing.
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.
Measured: After 7 days of dosing.
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.
Measured: After 7 days of dosing.
Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Measured: After 7 days of dosing.
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.
Measured: After 7 days of dosing.

Timeline

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

May 2009Sep 2009

First posted19 Feb 2009 (estimated)
Study startMay 2009
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal RefluxStudies 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00847210
Sponsor's protocol ID: T-P107-163
Other IDs: U1111-1114-1891
Status last verified: Jan 2012
First submitted: 18 Feb 2009
Last updated: 2 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
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Paraesophageal Hernia, GERD

All Gastroesophageal Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease
ClinicalTrials.gov ID: NCT00847210
Acronym / sponsor ID: T-P107-163
Conditions: Gastroesophageal Reflux
Keywords: Esophageal Reflux, Gastro-Esophageal Reflux, Gastroesophageal Reflux Disease, GERD, Regurgitation, Gastric, Heartburn, Drug Therapy, Adolescent
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 19 Feb 2009 (estimated)
Results: Posted 5 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dexlansoprazole MR 30 mg QD	Experimental	Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg QD	Experimental	Drug: Dexlansoprazole MR

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (15 listed)

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.

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
Dexlansoprazole MRAlso: TAK-390MR, Kapidex, DexilantDexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.	Drug	Dexlansoprazole MR 30 mg QD
Dexlansoprazole MRAlso: TAK-390MR, Kapidex, DexilantDexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.	Drug	Dexlansoprazole MR 60 mg QD

Primary outcome

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
Time frame: After 7 days of dosing.
Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.
Time frame: After 7 days of dosing.
Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.
Time frame: After 7 days of dosing.
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]).
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.
Time frame: After 7 days of dosing.
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).
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.
Time frame: After 7 days of dosing.
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Oral Clearance (CL/F) Pharmacokinetic Parameter.
Time frame: After 7 days of dosing.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.
Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.
Time frame: After 7 days of dosing.
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.
Time frame: After 7 days of dosing.
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.

Results and safety

Results posted to the registry on 5 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexlansoprazole MR 30 mg QD	18	18
Dexlansoprazole MR 60 mg QD	18	18

Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

Time frame: After 7 days of dosing.. Mean (Standard Deviation). Unit: hours

Measure	Dexlansoprazole MR 30 mg QD n = 17	Dexlansoprazole MR 60 mg QD n = 18
Value	4.65 (2.909)	3.31 (1.519)

Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD: p = 0.095, ANOVA

Population analysed: All participants who had Tmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the pharmacokinetic (PK) analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.

Primary outcome: Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.

Time frame: After 7 days of dosing.. Mean (Standard Deviation). Unit: ng/mL

Measure	Dexlansoprazole MR 30 mg QD n = 17	Dexlansoprazole MR 60 mg QD n = 18
Value	691 (367.5)	1136 (582.2)

Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD: ratio of the central values for Cmax: 1.210 (90% CI 0.897 to 1.630), p = 0.289, ANOVA

Population analysed: All participants who had Cmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.

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

Time frame: After 7 days of dosing.. Mean (Standard Deviation). Unit: ng*hr/mL/mg

Measure	Dexlansoprazole MR 30 mg QD n = 17	Dexlansoprazole MR 60 mg QD n = 18
Value	2842.32 (1313.827)	5113.72 (2987.508)

Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD: Ratio of the dose-normalized AUC(0-tlqc): 1.158 (90% CI 0.864 to 1.551), p = 0.402, ANOVA

Population analysed: All participants who had AUC(0-tlqc) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.

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

Time frame: After 7 days of dosing.. Mean (Standard Deviation). Unit: ng*hr/mL/mg

Measure	Dexlansoprazole MR 30 mg QD n = 16	Dexlansoprazole MR 60 mg QD n = 18
Value	2886.26 (1355.182)	5119.81 (2986.453)

Dexlansoprazole MR 30 mg QD vs Dexlansoprazole MR 60 mg QD: Ratio of the central values for dose-nor: 1.168 (90% CI 0.864 to 1.579), p = 0.388, ANOVA

Population analysed: All participants who had AUC(0-24) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexlansoprazole MR 30 mg QD	0 of 18 (0%)	7 of 18 (38.9%)	Not reported
Dexlansoprazole MR 60 mg QD	0 of 18 (0%)	5 of 18 (27.8%)	Not reported

Limitations and caveats (from the sponsor): For outcome measures #4, 5, 6, 7 and 8, outcomes could not be estimated for one participant in the 30 mg dose group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21716130Kukulka 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.
Dexilant Package InsertLink provided by the sponsor.

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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.

Medical Director Pharmacovigilance study director

Takeda

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexlansoprazole MR in people with Gastroesophageal Reflux, run by Takeda at 3 sites in United States.

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 15 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 5 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter (time frame: After 7 days of dosing.). 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?

On the ClinicalTrials.gov record for NCT00847210, which also lists 1 linked publication.

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 2 Feb 2012.