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Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01642615
First received: July 12, 2012
Last updated: May 8, 2015
Last verified: May 2015
Results First Received: May 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Gastroesophageal Reflux Disease
Erosive Esophagitis
Interventions: Drug: Dexlansoprazole
Drug: Placebo

  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 18 investigative sites in Mexico, Poland, Portugal and the United States from 22 June 2012 (first participant to sign the informed consent) to 10 November 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sixty three adolescents with a diagnosis of erosive esophagitis (EE) were enrolled in the dexlansoprazole delayed release 60 mg capsules open label phase. One participant was not treated. Participants with healed EE were randomized into one of 2 treatment groups: dexlansoprazole delayed release 30 mg capsules or placebo in the maintenance phase.

Reporting Groups
  Description
Healing Phase: Dexlansoprazole 60 mg Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
Maintenance Phase: Dexlansoprazole 30 mg Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
Maintenance Phase: Placebo Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.

Participant Flow for 2 periods

Period 1:   Open Label Maintenance Phase
    Healing Phase: Dexlansoprazole 60 mg   Maintenance Phase: Dexlansoprazole 30 mg   Maintenance Phase: Placebo
STARTED   63   0   0 
Safety Analysis Set   62   0   0 
COMPLETED   58   0   0 
NOT COMPLETED   5   0   0 
Pretreatment Event/Adverse Event                1                0                0 
Major Protocol Deviation                1                0                0 
Lost to Follow-up                1                0                0 
Voluntary Withdrawal                1                0                0 
Did not receive treatment                1                0                0 

Period 2:   Double Blind Maintenance Phase
    Healing Phase: Dexlansoprazole 60 mg   Maintenance Phase: Dexlansoprazole 30 mg   Maintenance Phase: Placebo
STARTED   0   25   26 
COMPLETED   0   18   20 
NOT COMPLETED   0   7   6 
Lack of Efficacy                0                1                3 
Voluntary Withdrawal                0                5                2 
Pretreatment Event/Adverse Event                0                1                0 
Requires Treatment with Another Drug                0                0                1 



  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.
Baseline measures are based on the Safety Analysis Set and included all enrolled participants who received at least one dose of study drug.

Reporting Groups
  Description
All Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 62 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.8  (1.64) 
Age, Customized 
[Units: Participants]
 
12 to 14 years   24 
15 to 17 years   38 
Gender 
[Units: Participants]
 
Female   24 
Male   38 
Race/Ethnicity, Customized 
[Units: Participants]
 
Not Hispanic or Latino   16 
Hispanic or Latino   6 
Not Collected outside the United States   40 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black or African American   1 
White   61 
Region of Enrollment 
[Units: Participants]
 
United States   22 
Portugal   4 
Poland   34 
Mexico   2 
Height 
[Units: Cm]
Mean (Standard Deviation)
 165.5  (9.68) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 61.86  (17.060) 
Body Mass Index (BMI) [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 22.34  (5.086) 
[1] BMI is calculated using the weight and height.
Smoking Classification 
[Units: Participants]
 
Never smoked   61 
Current smoker   1 
Ex-smoker   0 
Helicobacter pylori (H. pylori) Status 
[Units: Participants]
 
Positive   0 
Negative   61 
Unknown   1 
Erosive Esophagitis Present 
[Units: Participants]
 
Yes   62 
No   0 
Baseline EE Grade (LA Classification) [1] 
[Units: Participants]
 
 34 
 26 
 1 
 1 
[1] A=1 (or more) mucosal break 5 mm or less that does not extend between the tops of two mucosal folds, B=1 (or more) mucosal break more than 5 mm-long that does not extend between the tops of two mucosal folds, C=1 (or more) mucosal break that is continuous between the tops of two or more mucosal folds but that involves less than 75% of the circumference and D=1 (or more) mucosal break that involves at least 75% of the esophageal circumference.


  Outcome Measures
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1.  Primary:   Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period   [ Time Frame: 8 weeks ]

2.  Primary:   Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period   [ Time Frame: From Week 8 to Week 24 ]

3.  Secondary:   Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8   [ Time Frame: 8 weeks ]

4.  Secondary:   Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24   [ Time Frame: From Week 8 to Week 24 ]

5.  Secondary:   Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment   [ Time Frame: 8 weeks ]

6.  Secondary:   Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24   [ Time Frame: Weeks 8 to 24 ]


  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
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01642615     History of Changes
Other Study ID Numbers: TAK-390MR_207
U1111-1128-6117 ( Registry Identifier: WHO )
2012-001681-15 ( EudraCT Number )
Study First Received: July 12, 2012
Results First Received: May 8, 2015
Last Updated: May 8, 2015
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: Ministry of Health
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Portugal: National Pharmacy and Medicines Institute