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Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01642602
First received: July 12, 2012
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: July 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux Disease
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 the study at 36 sites in the United States, Belgium, Hungary, Italy, Poland, Portugal, Brazil, and Mexico from 22 June 2012 to 21 January 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Adolescent participants (male or female), aged 12 to 17 years (inclusive) with symptomatic non-erosive gastrointestinal reflux disease were enrolled in 1 group and received dexlansoprazole 30 mg orally once daily for up to 4 weeks.

Reporting Groups
  Description
Dexlansoprazole 30 mg Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.

Participant Flow:   Overall Study
    Dexlansoprazole 30 mg
STARTED   104 
COMPLETED   102 
NOT COMPLETED   2 
Adverse Event                2 



  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.
Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the appropriate efficacy variable.

Reporting Groups
  Description
Dexlansoprazole 30 mg Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.

Baseline Measures
   Dexlansoprazole 30 mg 
Overall Participants Analyzed 
[Units: Participants]
 104 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.0  (1.50) 
Age, Customized 
[Units: Participants]
 
12 to 14 years   34 
15 to 17 years   70 
Gender 
[Units: Participants]
 
Female   73 
Male   31 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black or African American   6 
White   95 
Multiracial   3 
Race/Ethnicity, Customized 
[Units: Participants]
 
Hispanic or Latino   19 
Non-Hispanic and Latino   47 
Not Collected   38 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 61.60  (14.393) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 163.1  (7.58) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 23.02  (4.434) 
Smoking Classification 
[Units: Participants]
 
Never Smoked   103 
Ex-smoker   1 
H pylori Status 
[Units: Participants]
 
Positive   14 
Negative   90 


  Outcome Measures
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1.  Primary:   Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period   [ Time Frame: 4 weeks ]

2.  Secondary:   The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment   [ Time Frame: 4 weeks ]


  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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  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: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01642602     History of Changes
Other Study ID Numbers: TAK-390MR_206
U1111-1128-5977 ( Registry Identifier: WHO )
2012-001680-72 ( EudraCT Number )
Study First Received: July 12, 2012
Results First Received: July 13, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Mexico: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Bulgaria: Ministry of Health
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Portugal: National Pharmacy and Medicines Institute