A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease

Condition(s) targeted: Crohn's Disease

Intervention: Crohn's Disease (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Prof. Jiri Nevoral, MD, PhD, Principal Investigator, Affiliation: Paediatric Clinic, Faculty Hospital Motol

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.

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 design: Prevention, Randomized, Single Blind, Active Control, Crossover Assignment

Primary outcome: To access the acceptability of Pentasa Sachets in comparison with the reference Pentasa tablets 500mg in children with Cohn's disease.

Secondary outcome:

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 Expected completion: May 2007

Detailed description: Screening: At screening a complete medical history including family history of IBD and physical examination, including height, weight, blood pressure, pulse rate and evaluation of the major organ systems will be conducted. Basic haematology, serum chemistry and urine analysis and stool microbiology will be performed. PCD Activity Index will be calculated. All above mentioned tests must be performed maximum 7 days prior the baseline visit.

Visit No. 1: The study medication for next 4 weeks will be dispensed according to the randomisation scheme in common dose 2× 1 g of Pentasa® Sachets 1 g or Pentasa® tablets 500 mg. The patient diary will be distributed. If the laboratory assessment for faecal pathogens is found to be positive, the patients will be excluded from the trial.

Visit No. 2 (week 4 +/- 4 days): If the patient does not meet any criteria for premature withdrawal the following actions have to be taken: checking the diaries, calculation of the PCD Activity Index, urine examination, physical global assessment, blood and urine sampling and adverse events assessment. In 6 randomly selected patients from each group, stool and urine will be taken to assess concentrations of mesalazine and N-acetylmesalazine. The medication will be switched to the second formulation of Pentasa® (granules × tablets) and it will be dispensed for the next 4 weeks.

Visit No. 3 (week 8 +/- 4 days): The same evaluations as during Visit No. 2, calculation of returned medication. If the patient is withdrawn before week 8, the patient should be seen as soon as possible, and the date of this visit should be registered as the Visit No. 3. In 6 patients from each group who underwent the monitoring of mesalazine and N-acetylmesalazine concentrations during the Visit No. 2, the same evaluation as during Visit No. 2 will be performed.

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

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

Faculty Hospital Motol, Paediatric Clinic, Czech Republic, Prague, Czech Republic

Starting date: December 2004
Ending date: February 2006
Last updated: April 11, 2007