CompletedPhase 4

Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis

Israel86 participantsStarted 2010-09

Plain-language summary

The purpose of this study is to evaluate effectiveness of once daily dosing of Pentasa compared with twice daily in children with mild to moderate active ulcerative colitis.

Who can participate

Age range6 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Children 6-18 years of age, weight least 15kg.
✓. Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
✓. Mild to moderate disease activity at the time of enrolment as judged by the Pediatric UC Activity Index (PUCAI) score 10-55 points.
✓. In general good health (other than the diagnosis of UC), based on medical history, physical examination, and screening laboratory results.
✓. Infectious colitis excluded by stool cultures, ova and parasite examination and Clostridium difficile assay.
✓. Ability and acceptance to participate in the study and follow study procedures, as evidenced by a parent/legal guardian signing a written informed consent and the child providing assent.

Exclusion criteria

✕. Weight \<15 kg at enrolment
✕. Patients whose disease is confined to the rectum (i.e. proctitis).
✕. Fever \>38.5 degrees.
✕. Patients with Crohn's colitis or with IBD type unclassified (IBD-U) according to Montreal classification.
✕. Treatment with oral 5-ASA oral preparation with at least 50mg/kg/day \> 3 days within 7 days prior to screening visit. Patients who are treated with 5-ASA \<50mg/kg/d may be enrolled as their dose will be increased significantly in this trial. A sensitivity analysis is planned including only 5-ASA naïve children.
✕. Exacerbation associated with infectious organism in the stool.
✕. Current treatment with steroids (any dose) or the need for steroid therapy as judged by the responsible gastroenterologist.
✕. Rectal therapies (suppositories, foams, enemas etc) of all kind are allowed if the dose and frequency has remained stable during the previous 30 days prior to the screening visit. No changes are allowed after randomization and until completion of the study.

What they're measuring

Difference in mean PUCAI score between the groups.

Timeframe: At week 6 after initiation of therapy.

Trial details

NCT IDNCT01201122

SponsorWolfson Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Mild to Moderate Ulcerative Colitis trials