Clinical Trial Results:
A Multicenter, Open-Label, Non-Comparative Study to Evaluate the Safety
of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in
Pediatric Subjects Aged 5 to 17 Years, Inclusive
Summary
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EudraCT number |
2011-003742-40 |
Trial protocol |
DE |
Global end of trial date |
13 Feb 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Feb 2017
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First version publication date |
09 Aug 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 |
D9422C00002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
AstraZeneca R&D
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Sponsor organisation address |
Pepparedsleden 1, Mölndal, Sweden, 431 83
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Public contact |
Tore Persson, AstraZeneca R&D, +46 31 7766069, tore.teb.persson@astrazeneca.com
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Scientific contact |
Stefan Eklund, MD, AstraZeneca R&D, Mölndal, +46 31 7762557, Stefan.Eklund@astrazeneca.co
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jan 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Feb 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Feb 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 primary objective of this study was to investigate the safety of Entocort™ EC in a
pediatric mild-to-moderate Crohn’s disease population for the maintenance of clinical
remission.
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Protection of trial subjects |
Subjects could discontinue IP and assessments at any time at the discretion of the investigator.
Subjects were also free to withdraw from the study at any time, without prejudice to further
treatment. Specific reasons for withdrawal of a subject from this study and the procedures to
be followed when a subject was withdrawn are listed in the CSP. For subjects
who were discontinued, the subjects and parents/guardians of the subject were asked about the
reasons for their discontinuation and about the presence of any Adverse events (AEs). If
possible, they were seen and underwent final assessment by the investigator. Adverse events
were followed, and any IPs and study materials were returned by the
subject/parents/guardians.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Dec 2011
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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 |
United States: 19
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Country: Number of subjects enrolled |
Canada: 9
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Country: Number of subjects enrolled |
European Union: 27
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Worldwide total number of subjects |
55
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EEA total number of subjects |
0
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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) |
7
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Adolescents (12-17 years) |
48
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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 |
Subjects could enter this study from the pediatric Entocort induction protocol (D9442C00001) but this was not mandatory. If subjects fulfilled the eligibility criteria as stated and were in Crohn’s disease clinical remission, they could enter this study. | ||||||||||||||||
Pre-assignment
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Screening details |
Subjects could enter this study from the pediatric Entocort induction protocol (D9442C00001) but this was not mandatory. If subjects fulfilled the eligibility criteria as stated and were in Crohn’s disease clinical remission, they could enter this study. | ||||||||||||||||
Period 1
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Period 1 title |
Full study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
Blinding implementation details |
Not blinded
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Arms
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Arm title
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Entocort | ||||||||||||||||
Arm description |
Entocort EC 6 mg/day for 8 weeks, then 3 mg/day for 2 weeks, then no drug for 2 weeks | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Entocort EC
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
6 mg/day
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Baseline characteristics reporting groups [1]
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Reporting group title |
Full study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same. Justification: 55 patients were screened/enrolled, but only 50 of them met the inclusion/exclusion criteria; all analyses are based on these 50. |
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Subject analysis sets
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Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The safety analysis set consisted of all subjects who took at least 1 dose of Entocort™ EC.
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Subject analysis set title |
Full analysis set (FAS)
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The FAS consisted of all subjects included in the safety analysis set who had a complete post
baseline (Visit 4) data for PCDAI assessment.
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End points reporting groups
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Reporting group title |
Entocort
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Reporting group description |
Entocort EC 6 mg/day for 8 weeks, then 3 mg/day for 2 weeks, then no drug for 2 weeks | ||
Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety analysis set consisted of all subjects who took at least 1 dose of Entocort™ EC.
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Subject analysis set title |
Full analysis set (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The FAS consisted of all subjects included in the safety analysis set who had a complete post
baseline (Visit 4) data for PCDAI assessment.
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End point title |
Patients with adverse events [1] | ||||||
End point description |
Did the patient have an adverse event?
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End point type |
Primary
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End point timeframe |
12 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: Since this study only had one arm, only descriptive statistics has been used. No comparisons, no statistical tests and no confidence intervals. |
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No statistical analyses for this end point |
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End point title |
Change in PCDAI | ||||||||
End point description |
Pediatric Crohn’s disease activity index
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End point type |
Secondary
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End point timeframe |
12 weeks
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No statistical analyses for this end point |
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End point title |
Change in IMPACT III | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12 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 |
12 weeks
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1.1
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Reporting groups
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Reporting group title |
Safety population
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |