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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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28 February 2019 |
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Main ID: |
EUCTR2010-022017-26-GB |
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Date of registration:
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08/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease
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Scientific title:
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A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease |
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Date of first enrolment:
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07/01/2011 |
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Target sample size:
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27 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022017-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other: yes
Other specify the comparator: alternate-day therapy versus daily dose therapy
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1) patients aged 8 to 17 years
2) diagnosis of Crohn’s disease by established clinical, endoscopic, histological and radiological criteria
3) clinically active disease defined as a paediatric Crohn’s disease activity index (PCDAI) score of >15
4) clinical decision made to commence oral prednisolone
5) parental and child consent to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1) severe CD requiring intravenous corticosteroids or likely to require surgery,
2) having received systemic corticosteroids during the preceding 6 months.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Crohn's disease
MedDRA version: 12.
Level: LLT
Classification code 10013099
Term: Disease Crohns
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Intervention(s)
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Product Name: Prednisolone
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: Prednisolone
CAS Number: 125-02-0
Concentration unit: mg milligram(s)
Concentration type: equal
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Primary Outcome(s)
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Main Objective: To investigate the feasibility of a RCT to compare an alternate-day prednisolone regimen with a daily-dose regimen:
a. to assess whether the research protocol is realistic and workable
b. to identify logistical problems which might occur using the proposed protocol
c. to assess the likely success of recruitment and determine period of recruitment
d. to determine if there is likely to be significant attrition
e. to determine what resources (finance, staff) will be needed for the main study
f. to test the outcome measures and their suitability, practicality, statistical properties and utility.
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Primary end point(s): Clinical Remission
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Secondary Objective: To collect preliminary data on:
a. disease activity, quality of life
b. biochemical markers of bone formation and bone resorption,
c. insulin-like growth factor-I (IGF-1)
d. adrenal responsiveness to ACTH
e. adverse effects (such as hyperglycaemia, hypertension, infections, peptic ulcer, moon face, obesity, hirsutism, and acne)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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