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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022017-26-GB

Enrollment

Registered

2010-12-08

Start date

2011-01-07

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease MedDRA version: 12. Level: LLT Classification code 10013099 Term: Disease Crohns

Interventions

Product Name: Prednisolone Pharmaceutical Form: Soluble tablet INN or Proposed INN: Prednisolone CAS Number: 125-02-0 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1) severe CD requiring intravenous corticosteroids or likely to require surgery, 2) having received systemic corticosteroids during the preceding 6 months.

Design outcomes

Primary

Measure	Time frame
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) ; 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. ;Primary end point(s): Clinical Remission	—

Measure

Time frame

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) ; 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. ;Primary end point(s): Clinical Remission

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026