Phase III Multicentre trial of oral mesalazine in patients with mild to moderate ulcerative colitis
Research type
Research Study
Full title
Phase III multicentre trial of oral mesalazine in patients with mild to moderate ulcerative colitis (CGRA-0121/ES).
IRAS ID
1008742
Contact name
Inmaculada Gilaberte
Contact email
Sponsor organisation
FAES FARMA, S.A.
Clinicaltrials.gov Identifier
Research summary
Ulcerative colitis (UC) is a long term condition where the colon and bowel become inflamed.
The trial treatment, Mesalazine is already used to treat patients with ulcerative colitis and has shown to provide therapeutical benefits for maintenance and remission of UC. Mesalazine is commonly taken in oral form, which can be difficult to take. This trial is looking at providing an alternative form of Mesalazine, provided as an oral Mesalazine formulation which may be easier for the patient to take. The aim of the trial is to prove that this formulation is as effective as the currently available form as a treatment for the induction of remission in patients with active mild to moderate UC. Patients with active mild to moderate UC, aged 18 years of age or older with symptoms of UC for at least 3 months prior to taking part in the study will be considered for inclusion. Trial subjects will be required to attend 4 on-site visits including a screening visit, baseline visit and 2 'on-study' visits. In addition there will be 3 telephone calls, at week 2, week 6 and follow up call at week 10 (follow up period is two weeks). Once the subject has consented to take part, they will be assigned to one of the two treatment arms on a 1:1 ratio and will receive either the currently used oral Mesalazine treatment with a placebo of the test oral Mesalazine oral formulation, or the test Mesalazine oral formulation with placebo oral Mesalazine to be taken once a day. The study has a screening period up to 38 days, an 8 week treatment period and a 1 week follow up period. A total of up to 15 weeks and 3 days. Subjects will be required to have at least one endoscopy as part of the study. Additional assessments include blood samples, a daily e-diary completed, questionnaires, stool sample, and medical history checks, physical exam, data collection and height and weight will be performed.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0030
Date of REC Opinion
9 Apr 2024
REC opinion
Further Information Favourable Opinion