Clinical trial NCT00225810: A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease
Official title: Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the acceptability of Pentasa Sachets in comparison with the reference Pentasa tablets 500mg in children with Cohn's disease.
Secondary outcomes:
measure: To compare the safety of both formulations of Pentasa.
measure: To compare the concentration of mesalazine and N-acetylmesalazine in urine and stool during the administration of both formulations of Pentasa.
measure: 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.
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Faculty Hospital Bulovka, Paediatric Clinic
city: Prague
country: Czech Republic
facility: Faculty Hospital Motol, Paediatric Clinic
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: