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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1112-1684 | Registry Identifier | WHO |
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The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
Gastroesophageal Reflux Disease (GERD) is a condition of several causes resulting in the backward flow of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of GERD in the pediatric population is increasingly becoming recognized and documented. It is a disease that may persist through adulthood, with symptoms in older children and adolescents similar to those seen in adults.
Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type GERD symptoms of heartburn and regurgitation. Treatment for GERD is aimed at improving symptoms and healing esophageal inflammation.
Takeda Global Research & Development Center, Inc. (TGRD) developed dexlansoprazole delayed release capsules as a new therapy for treating acid related disorders including symptomatic non-erosive GERD, healing of erosive esophagitis (EE) and maintenance of healed EE.
Dexlansoprazole delayed release capsules have not been studied in subjects younger than 12 years of age. This study is designed to evaluate the safety of dexlansoprazole delayed release capsules in the pediatric population (1 to 11 years old) and to determine if the PK profile of dexlansoprazole in subjects 1 to 11 years of age is similar to that in adults given a similar dose.
Subjects who satisfy the screening evaluation and Inclusion/Exclusion Criteria may be enrolled in the study. Eligible subjects will be assigned to one of three treatment groups. Attempts will be made to enroll an equal number of male and female subjects in each treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexlansoprazole 15 mg QD | Experimental |
| |
| Dexlansoprazole 30 mg QD | Experimental |
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| Dexlansoprazole 60 mg QD | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole | Drug | Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach the Peak Plasma Concentration (Tmax) | Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
| The Peak Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)) | AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)) | AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized Peak Plasma Concentration (Cmax/Dose) | Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | United States | ||||
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| Label | URL |
|---|---|
| Dexilant Package Insert | View source |
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36 participants with gastroesophageal reflux disease were assigned to 1 of 3 once daily (QD) treatment regimens (15 mg, 30 mg or 60 mg dexlansoprazole) based on baseline body weight.
Participants took part in this study at 3 investigative sites in the United States from 04 March 2010 to 09 February 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexlansoprazole 15 mg QD | Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days. |
| FG001 | Dexlansoprazole 30 mg QD | Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dexlansoprazole | Drug | Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days |
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| Dexlansoprazole | Drug | Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days |
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| Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose) | AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
| Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose) | AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
| Miami Garden |
| Florida |
| United States |
| Kansas City | Missouri | United States |
| Cincinnati | Ohio | United States |
| FG002 | Dexlansoprazole 60 mg QD | Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days |
| Pharmacokinetic Set |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexlansoprazole 15 mg QD | Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days. |
| BG001 | Dexlansoprazole 30 mg QD | Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days |
| BG002 | Dexlansoprazole 60 mg QD | Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Mean height | Height for one patient in the Dexlansoprazole 15 mg group was incorrectly reported (as 38 cm instead of 96.52 cm) and is included in the mean height reported here. The mean height excluding this patient is 97.45 cm. | Mean | Standard Deviation | cm |
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| Overall Mean Weight | Mean | Standard Deviation | kg |
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| Number of Participants per Weight Group | Number | participants |
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| Mean Weight per Weight Group | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Height for one patient in the Dexlansoprazole 15 mg group was incorrectly reported (as 38 cm instead of 96.52 cm) and is included in the mean BMI reported here. The mean BMI excluding this patient is 16.52 kg/m^2. | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Reach the Peak Plasma Concentration (Tmax) | Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Pharmacokinetic (PK) set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7. | Posted | Mean | Standard Deviation | hours | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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| Other Pre-specified | Dose-normalized Peak Plasma Concentration (Cmax/Dose) | Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7. | Posted | Mean | Standard Deviation | ng/mL/mg | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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| Other Pre-specified | Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose) | AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7. | Posted | Mean | Standard Deviation | ng*hr/mL/mg | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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| Other Pre-specified | Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose) | AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7. | Posted | Mean | Standard Deviation | ng*hr/mL/mg | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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| Primary | The Peak Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7. | Posted | Mean | Standard Deviation | ng/mL | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)) | AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)) | AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. | Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. |
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Treatment-emergent adverse events are adverse events with an onset that occurred after receiving study drug and within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexlansoprazole 15 mg QD | Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days. | 0 | 12 | 5 | 12 | ||
| EG001 | Dexlansoprazole 30 mg QD | Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days | 0 | 12 | 2 | 12 | ||
| EG002 | Dexlansoprazole 60 mg QD | Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days | 1 | 12 | 3 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of it's obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research and Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Non-Hispanic or Latino |
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| White |
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| Multiracial |
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| 12.7 kg - < 25.4 kg |
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| ≥ 25.4 kg |
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| 12.7 kg - < 25.4 kg |
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| ≥ 25.4 kg |
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