Clinical Trial Results:
A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Summary
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EudraCT number |
2012-001680-72 |
Trial protocol |
HU PT BE IT |
Global end of trial date |
21 Jan 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Mar 2016
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First version publication date |
15 Jul 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TAK-390MR_206
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01642602 | ||
WHO universal trial number (UTN) |
U1111-1128-5977 | ||
Sponsors
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Sponsor organisation name |
Takeda Development Centre Europe Ltd.
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Sponsor organisation address |
61 Aldwych, London, United Kingdom, WC2B 4AE
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Public contact |
Program Manager, Takeda Development Centre Europe Ltd., 0044 20 3116 8000, clinicaloperations@tgrd.com
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Scientific contact |
Program Manager, Takeda Development Centre Europe Ltd., 0044 20 3116 8000, clinicaloperations@tgrd.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Jan 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Jan 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jan 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux Disease (GERD).
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Protection of trial subjects |
All study participants were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 7
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Country: Number of subjects enrolled |
Portugal: 6
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Country: Number of subjects enrolled |
Belgium: 1
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Country: Number of subjects enrolled |
Hungary: 11
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
United States: 66
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Country: Number of subjects enrolled |
Mexico: 10
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Country: Number of subjects enrolled |
Brazil: 2
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Worldwide total number of subjects |
104
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EEA total number of subjects |
26
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
104
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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Screening details |
Adolescent subjects (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 a day for 4 weeks. | ||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Dexlansoprazole 30 mg | ||||||||||
Arm description |
Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Dexlansoprazole
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Investigational medicinal product code |
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Other name |
Dexilant
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Pharmaceutical forms |
Prolonged-release capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
Dexlansoprazole delayed-release capsules.
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Baseline characteristics reporting groups
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Reporting group title |
Dexlansoprazole 30 mg
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Reporting group description |
Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dexlansoprazole 30 mg
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Reporting group description |
Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. | ||
Subject analysis set title |
Full analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
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.
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End point 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 [1] | ||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
4 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed as there is only 1 reporting group. |
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No statistical analyses for this end point |
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End point title |
The percentage of days with neither daytime nor nighttime heartburn over the 4 weeks of treatment | ||||||||
End point description |
Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.
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End point type |
Secondary
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End point timeframe |
4 weeks
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
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.
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Assessment type |
Systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Dexlansoprazole 30 mg
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Reporting group description |
Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks. | ||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |