Status:
COMPLETED
A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Crohn's Disease
Eligibility:
All Genders
8-18 years
Phase:
PHASE4
Brief Summary
The primary objective of the clinical trial is the assessment of the acceptability of the new Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500 mg in childre...
Eligibility Criteria
Inclusion
- Established diagnose of Crohn's disease
- Age 8-18 years, both sexes
- Weight above 40 kg
- Oral maintenance treatment with 5-ASA and any concomitant antinflammatory medication (maintained at the same dose during the study) before inclusion is permitted,
- written informed consent obtained (patient and his/her guardian)
Exclusion
- Patients with a history of allergy to salicylates
- Patients with known significant hepatic or renal function abnormalities
- Positive enteric pathogens in stool (Salmonella, Shigella, Yersinia, Campylobacter)
- Pregnant or lactating women
- Patients with a known history of disease, including mental/emotional disorder, that would interfere with their participation in the study,
- Patients who participated in another clinical study in the last 3 months,
- Patients who are unable to comply with the requirements of the protocol
- Patients who are unable to fill in the diary cards
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00225810
Start Date
October 1 2005
End Date
February 1 2006
Last Update
May 19 2011
Active Locations (2)
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1
Faculty Hospital Bulovka, Paediatric Clinic
Prague, Czechia
2
Faculty Hospital Motol, Paediatric Clinic
Prague, Czechia