Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets versus Pentasa® tbl. 500mg in Children with Crohn´s Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002802-31-CZ

Enrollment

Registered

2004-12-02

Start date

2005-01-25

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

children patients with the Crohn s disease in any stage (where mesalazine treatment is appropriate)

Interventions

Trade Name: Pentasa (R) Sachet Product Name: Pentasa (R) Sachet Pharmaceutical Form: Granules INN or Proposed INN: mesalazine Concentration unit: g gram(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Established diagnosis 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) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with a history of allergy to salicylates. Patients with known significant hepatic or renal function abnormalities Positive enteric pathogens in stool (Salmonela, 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
Main Objective: To assess the acceptability of Pentasa® Sachets in comparisson with the reference Pentasa® tablets 500 mg in children with Crohn’s disease. ;Secondary Objective: To compare the safety of both formulations of Pentasa To compare the concentrations of mesalazine and N-acetyl-mesalazine in urine and stool during the administration of both formulations of Pentasa To compare the PCD activity index at Week 4 and 8 ;Primary end point(s): Preparation of the drug, Appearance of the drug, Taste of the drug, Smell of the drug, Swallowing of the drug, Feelings after swallowing the drug, Eructation, Flatulence and Heartburn	—

Measure

Time frame

Main Objective: To assess the acceptability of Pentasa® Sachets in comparisson with the reference Pentasa® tablets 500 mg in children with Crohn’s disease. ;Secondary Objective: To compare the safety of both formulations of Pentasa To compare the concentrations of mesalazine and N-acetyl-mesalazine in urine and stool during the administration of both formulations of Pentasa To compare the PCD activity index at Week 4 and 8 ;Primary end point(s): Preparation of the drug, Appearance of the drug, Taste of the drug, Smell of the drug, Swallowing of the drug, Feelings after swallowing the drug, Eructation, Flatulence and Heartburn

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026