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

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ClinicalTrials.gov Identifier: NCT01642602
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux Disease
Intervention Drug: Dexlansoprazole
Enrollment 104

Recruitment Details 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 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.
Arm/Group Title Dexlansoprazole 30 mg
Hide Arm/Group Description Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Period Title: Overall Study
Started 104
Completed 102
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Dexlansoprazole 30 mg
Hide Arm/Group Description Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Overall Number of Baseline Participants 104
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants
15.0  (1.50)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants
12 to 14 years 34
15 to 17 years 70
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Female
73
  70.2%
Male
31
  29.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants
Black or African American 6
White 95
Multiracial 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants
Hispanic or Latino 19
Non-Hispanic and Latino 47
Not Collected 38
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 104 participants
61.60  (14.393)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 104 participants
163.1  (7.58)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 104 participants
23.02  (4.434)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants
Never Smoked 103
Ex-smoker 1
H pylori Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants
Positive 14
Negative 90
1.Primary Outcome
Title Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period
Hide Description A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least 1 dose of study drug.
Arm/Group Title Dexlansoprazole 30 mg
Hide Arm/Group Description:
Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Overall Number of Participants Analyzed 104
Measure Type: Number
Unit of Measure: Percentage of participants
Diarrhoea 6.7
Headache 6.7
2.Secondary Outcome
Title The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment
Hide Description Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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 efficacy variable.
Arm/Group Title Dexlansoprazole 30 mg
Hide Arm/Group Description:
Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Overall Number of Participants Analyzed 104
Median (Full Range)
Unit of Measure: Percentage of days
47.3
(0 to 100)
Time Frame A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug
Adverse Event Reporting Description 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.
 
Arm/Group Title Dexlansoprazole 30 mg
Hide Arm/Group Description Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
All-Cause Mortality
Dexlansoprazole 30 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexlansoprazole 30 mg
Affected / at Risk (%)
Total   0/104 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dexlansoprazole 30 mg
Affected / at Risk (%)
Total   14/104 (13.46%) 
Gastrointestinal disorders   
Diarrhoea  1  7/104 (6.73%) 
Nervous system disorders   
Headache  1  7/104 (6.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: 800-778-2860
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 )
First Submitted: July 12, 2012
First Posted: July 17, 2012
Results First Submitted: July 13, 2014
Results First Posted: August 6, 2014
Last Update Posted: August 6, 2014