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Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847210
First Posted: February 19, 2009
Last Update Posted: February 2, 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: September 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Intervention: Drug: Dexlansoprazole MR

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 3 investigative sites in the United States from 31 May 2009 to 10 September 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled in one of two, dexlansoprazole modified release (MR), once-daily (QD) treatment groups. 100% of participants randomized completed this study.

Reporting Groups
  Description
Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.

Participant Flow:   Overall Study
    Dexlansoprazole MR 30 mg QD   Dexlansoprazole MR 60 mg QD
STARTED   18   18 
COMPLETED   18   18 
NOT COMPLETED   0   0 



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

Baseline Measures
   Dexlansoprazole MR 30 mg QD   Dexlansoprazole MR 60 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.6  (1.65)   14.6  (1.89)   14.6  (1.75) 
Gender 
[Units: Participants]
     
Female   11   11   22 
Male   7   7   14 
Region of Enrollment 
[Units: Participants]
     
United States   18   18   36 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter   [ Time Frame: After 7 days of dosing. ]

2.  Primary:   Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.   [ Time Frame: After 7 days of dosing. ]

3.  Primary:   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. ]

4.  Primary:   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. ]

5.  Primary:   Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.   [ Time Frame: After 7 days of dosing. ]

6.  Primary:   Oral Clearance (CL/F) Pharmacokinetic Parameter.   [ Time Frame: After 7 days of dosing. ]

7.  Primary:   Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.   [ Time Frame: After 7 days of dosing. ]

8.  Primary:   Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.   [ Time Frame: After 7 days of dosing. ]


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


  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:
unchecked 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.
unchecked 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.


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


Publications of Results:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00847210     History of Changes
Other Study ID Numbers: T-P107-163
U1111-1114-1891 ( Registry Identifier: WHO )
First Submitted: February 18, 2009
First Posted: February 19, 2009
Results First Submitted: September 8, 2010
Results First Posted: October 5, 2010
Last Update Posted: February 2, 2012



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