Crohn's Disease
Conditions
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.
Interventions
DRUGCrohn's Disease
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the acceptability of Pentasa Sachets in comparison with the reference Pentasa tablets 500mg in children with Cohn's disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Czechia
Outcome results
None listed