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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01045096
First Posted: January 8, 2010
Last Update Posted: April 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: January 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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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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.
No text entered.

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 
Overall Participants Analyzed 
[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) 
[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.
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 [1] 
[Units: Kg]
Mean (Standard Deviation)
       
8.6 kg - < 12.7 kg   11.1  (1.05)   NA [1]   NA [1]   11.1  (1.05) 
12.7 kg - < 25.4 kg   19.0  (4.76)   20.3  (3.67)   NA [1]   19.6  (4.17) 
≥ 25.4 kg   NA [1]   39.1  (9.19)   41.0  (8.50)   40.3  (8.51) 
[1] There were no participants in this group
Body Mass Index (BMI) [1] 
[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 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. ]
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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.  

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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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. ]

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. ]

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. ]

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. ]

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. ]

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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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