Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takeda Global Research & Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT01045096

First received: January 7, 2010

Last updated: March 8, 2012

Last verified: March 2012

History of Changes

Results First Received: January 30, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Open Label
Condition:	Gastroesophageal Reflux
Intervention:	Drug: Dexlansoprazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in this study at 3 investigative sites in the United States from 04 March 2010 to 09 February 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Participant Flow: Overall Study

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
STARTED	12	12	12
Pharmacokinetic Set	9 ^[1]	11	11
COMPLETED	9	12	12
NOT COMPLETED	3	0	0
Withdrawal by Subject	2	0	0
Other	1	0	0

[1]	All patients with at least one estimable PK parameter for dexlansoprazole on Day 7.

Baseline Characteristics

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Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Total	Total of all reporting groups

Baseline Measures

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD	Total
Number of Participants [units: participants]	12	12	12	36
Age [units: years] Mean ± Standard Deviation	3.3 ± 1.97	7.8 ± 2.89	10.2 ± 0.72	7.1 ± 3.50
Gender [units: participants]
Female	5	2	5	12
Male	7	10	7	24
Race/Ethnicity, Customized [units: participants]
Hispanic or Latino	6	8	8	22
Non-Hispanic or Latino	6	4	4	14
Race/Ethnicity, Customized [units: participants]
Black or African American	2	0	0	2
White	8	12	12	32
Multiracial	2	0	0	2
Region of Enrollment [units: participants]
United States	12	12	12	36
Mean height ^[1] [units: cm] Mean ± Standard Deviation	92.5 ± 24.16	131.9 ± 18.80	146.3 ± 8.73	123.6 ± 29.17
Overall Mean Weight [units: kg] Mean ± Standard Deviation	15.7 ± 5.43	29.7 ± 11.86	41.0 ± 8.50	28.8 ± 13.64
Number of Participants per Weight Group [units: participants]
8.6 kg - < 12.7 kg	5	0	0	5
12.7 kg - < 25.4 kg	7	6	0	13
≥ 25.4 kg	0	6	12	18
Mean Weight per Weight Group [units: kg] Mean ± Standard Deviation
8.6 kg - < 12.7 kg	11.1 ± 1.05	NA ± NA ^[2]	NA ± NA ^[2]	11.1 ± 1.05
12.7 kg - < 25.4 kg	19.0 ± 4.76	20.3 ± 3.67	NA ± NA ^[2]	19.6 ± 4.17
≥ 25.4 kg	NA ± NA ^[2]	39.1 ± 9.19	41.0 ± 8.50	40.3 ± 8.51
Body Mass Index (BMI) ^[3] [units: kg/m^2] Mean ± Standard Deviation	22.3 ± 20.08	16.4 ± 3.09	19.0 ± 2.56	19.2 ± 11.73

[1]	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.
[2]	There were no participants in this group
[3]	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.

Outcome Measures

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1. Primary:

Time to Reach the Peak Plasma Concentration (Tmax) [ Time Frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. ]

Measure Type	Primary
Measure Title	Time to Reach the Peak Plasma Concentration (Tmax)
Measure Description	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.
Time Frame	Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic (PK) set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Measured Values

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
Number of Participants Analyzed [units: participants]	9	11	11
Time to Reach the Peak Plasma Concentration (Tmax) [units: hours] Mean ± Standard Deviation	4.4 ± 3.18	4.1 ± 2.34	4.1 ± 3.59

Statistical Analysis 1 for Time to Reach the Peak Plasma Concentration (Tmax)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.809

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An analysis of variance with covariates (ANCOVA) model with weight as a covariate and regimen as a factor were fitted to Tmax. Pairwise comparisons between regimens were conducted.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Primary:

The Peak Plasma Concentration (Cmax) [ Time Frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. ]

Measure Type	Primary
Measure Title	The Peak Plasma Concentration (Cmax)
Measure Description	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.
Time Frame	Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Measured Values

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
Number of Participants Analyzed [units: participants]	9	11	11
The Peak Plasma Concentration (Cmax) [units: ng/mL] Mean ± Standard Deviation	559 ± 225.3	1005 ± 748.1	964 ± 519.0

No statistical analysis provided for The Peak Plasma Concentration (Cmax)

3. Primary:

Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)) [ Time Frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. ]

Measure Type	Primary
Measure Title	Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))
Measure Description	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.
Time Frame	Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Measured Values

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
Number of Participants Analyzed [units: participants]	9	11	11
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)) [units: ng*hr/mL] Mean ± Standard Deviation	1914 ± 631.8	2892 ± 1668.6	3747 ± 2795.6

No statistical analysis provided for Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))

4. Primary:

Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)) [ Time Frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. ]

Measure Type	Primary
Measure Title	Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))
Measure Description	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.
Time Frame	Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Measured Values

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
Number of Participants Analyzed [units: participants]	6	8	6
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)) [units: ng*hr/mL] Mean ± Standard Deviation	2149 ± 563.7	2628 ± 1383.2	3330 ± 1883.3

No statistical analysis provided for Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))

5. Other Pre-specified:

Dose-normalized Peak Plasma Concentration (Cmax/Dose) [ Time Frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. ]

Measure Type	Other Pre-specified
Measure Title	Dose-normalized Peak Plasma Concentration (Cmax/Dose)
Measure Description	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.
Time Frame	Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Measured Values

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
Number of Participants Analyzed [units: participants]	9	11	11
Dose-normalized Peak Plasma Concentration (Cmax/Dose) [units: ng/mL/mg] Mean ± Standard Deviation	37.3 ± 15.02	33.5 ± 24.94	16.1 ± 8.65

Statistical Analysis 1 for Dose-normalized Peak Plasma Concentration (Cmax/Dose)

Groups ^[1]	Dexlansoprazole 15 mg QD vs. Dexlansoprazole 30 mg QD
Dose Proportionality Point Estimate ^[2]	1.20
90% Confidence Interval	( 0.660 to 2.183 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Dose-normalized Peak Plasma Concentration (Cmax/Dose)

Groups ^[1]	Dexlansoprazole 15 mg QD vs. Dexlansoprazole 60 mg QD
Dose proportionality Point Estimate ^[2]	1.06
90% Confidence Interval	( 0.463 to 2.427 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Dose-normalized Peak Plasma Concentration (Cmax/Dose)

Groups ^[1]	Dexlansoprazole 30 mg QD vs. Dexlansoprazole 60 mg QD
Dose Proportionality Point Estimate ^[2]	0.88
90% Confidence Interval	( 0.493 to 1.579 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

6. 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) [ Time Frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. ]

Measure Type	Other Pre-specified
Measure Title	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)
Measure Description	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.
Time Frame	Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Measured Values

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
Number of Participants Analyzed [units: participants]	9	11	11
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) [units: ng*hr/mL/mg] Mean ± Standard Deviation	128 ± 42.1	96 ± 55.6	62 ± 46.6

Statistical Analysis 1 for 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)

Groups ^[1]	Dexlansoprazole 15 mg QD vs. Dexlansoprazole 30 mg QD
Dose Proportionality Point Estimate ^[2]	1.13
90% Confidence Interval	( 0.693 to 1.848 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-tlqc]. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for 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)

Groups ^[1]	Dexlansoprazole 15 mg QD vs. Dexlansoprazole 60 mg QD
Dose Proportionality Point Estimate ^[2]	1.15
90% Confidence Interval	( 0.584 to 2.276 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-tlqc]. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for 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)

Groups ^[1]	Dexlansoprazole 30 mg QD vs. Dexlansoprazole 60 mg QD
Dose Proportionality Point Estimate ^[2]	1.02
90% Confidence Interval	( 0.632 to 1.642 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-tlqc]. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

7. 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) [ Time Frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules. ]

Measure Type	Other Pre-specified
Measure Title	Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)
Measure Description	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.
Time Frame	Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.

Reporting Groups

	Description
Dexlansoprazole 15 mg QD	Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg QD	Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg QD	Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Measured Values

	Dexlansoprazole 15 mg QD	Dexlansoprazole 30 mg QD	Dexlansoprazole 60 mg QD
Number of Participants Analyzed [units: participants]	6	8	6
Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose) [units: ng*hr/mL/mg] Mean ± Standard Deviation	143.2 ± 37.58	87.6 ± 46.11	55.5 ± 31.39

Statistical Analysis 1 for Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)

Groups ^[1]	Dexlansoprazole 15 mg QD vs. Dexlansoprazole 30 mg QD
Dose Proportionality Point Estimate ^[2]	1.06
90% Confidence Interval	( 0.692 to 1.636 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-24]. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)

Groups ^[1]	Dexlansoprazole 15 mg QD vs. Dexlansoprazole 60 mg QD
Dose Proportionality Point Estimate ^[2]	1.26
90% Confidence Interval	( 0.691 to 2.314 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-24]. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)

Groups ^[1]	Dexlansoprazole 30 mg QD vs. Dexlansoprazole 60 mg QD
Dose Proportionality Point Estimate ^[2]	1.19
95% Confidence Interval	( 0.777 to 1.817 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-24]. Pairwise comparisons between regimens were conducted.
[2]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT01045096 History of Changes
Other Study ID Numbers:	T-P107-174, U1111-1112-1684
Study First Received:	January 7, 2010
Results First Received:	January 30, 2012
Last Updated:	March 8, 2012
Health Authority:	United States: Food and Drug Administration

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