A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00225810
- Lead Sponsor
- Ferring Pharmaceuticals
- 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 children with Crohn's disease. After the screening period (which includes medical history, physical examination, basic haematology, serum chemistry , urine analysis and stool microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose 2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will record the acceptability of the both forms of the medication.
In 6 patients from each group (selected by the randomization), stool and urine will be taken to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3. Adverse events will be recorded during the whole course of the treatment period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method To assess the acceptability of Pentasa Sachets in comparison with the reference Pentasa tablets 500mg in children with Cohn's disease.
- Secondary Outcome Measures
Name Time Method To compare the safety of both formulations of Pentasa. To compare the concentration of mesalazine and N-acetylmesalazine in urine and stool during the administration of both formulations of Pentasa. To compare the PCD activity index at Week 4 and 8 Phase IV Study design: instead of Single Blind use Open Total enrollment: 29 patients.
Trial Locations
- Locations (2)
Faculty Hospital Motol, Paediatric Clinic
🇨🇿Prague, Czech Republic
Faculty Hospital Bulovka, Paediatric Clinic
🇨🇿Prague, Czech Republic