Multicentre, controlled, randomized, investigator-blinded, comparative study of oral mesalazine 4g per day once daily versus 4g per day in two divided doses in patients with active ulcerative colitis. - MOTUS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 398

Inclusion Criteria

•Aged over 18 years.
•Newly diagnosed or relapsing mild to moderate ulcerative colitis with disease extension beyond rectum (of at least 12-18 cm from the anorectal junction). All patients must have had at least one total colonoscopy in their disease history (within the previous 5 years).
•Disease activity will be assessed within 15 days before inclusion and according to the ulcerative colitis disease activity index (UC-DAI) score. The UC-DAI score will be from 3 to 8 (mild: 3-5 or moderate: 6-8).
•Men or non pregnant women.
•Women with childbearing potential must be using a contraceptive method judged effective by the investigator.
•Oral maintenance treatment with azathioprine or 6-mercaptopurine (taken for at least 6 months and continued at the same dose throughout the study) is permitted.
•Informed consent given.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Proctitis (less than 12-18 cm from the anorectal junction).
•Previous colonic surgery.
•Previously failed to respond to steroids within the previous year.
•Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose > 3/day for induction of remission within the previous year.
•Current relapse lasting more than 6 weeks. For the patient recently diagnosed, the period of 6 weeks runs from the endoscopic diagnosis (from what patient says).
•Severe/fulminant ulcerative colitis.
•Evidence of other forms of inflammatory bowel disease or infectious disease.
•Allergy to aspirin or salicylate derivatives.
•The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary):
- Loperamide and other antidiarrheal agents, mucilages, antibiotics: 1 week wash-out.
- Oral steroids: 4 week wash-out.
- Rectal steroids: 2 week wash-out
- Repeated treatment (> 3days of use) of non steroidal anti-inflammatory drugs
(NSAID) oral or rectal route: 1 week wash-out (aspirin =325 mg/day used for
cardioprotection is allowed).
- Sulfasalazine > 4g/day or mesalazine or 4-ASA at a higher dose than what it is
permitted in the local formulary or standard care for maintenance treatment: 4
week wash-out.
- Immunomodulating/suppressing drugs: 3 month for wash out (except for
patients maintained on azathioprine or 6-mercaptopurine).
•Known significant hepatic or renal function abnormalities.
•Moderate/severe abnormal renal, hepatic or blood count tests defined as: creatinine plasma value > 1.5 x ULN or white blood cells < 3500/mm3 or > 15000/mm3 or platelets < 100000/mm3 or > 800000/mm3 or ASAT/ALAT > 3 x ULN or GGT/Alkalin Phosphatases > 3x ULN (Primary Sclerosing Cholangitis is not an exclusion criteria).
•History or physical examination findings indicative of active alcohol or drug abuse.
•Pregnancy or breast-feeding.
•History of disease, including mental/emotional disorder, that might interfere with their participation in the study.
•Participation in another clinical study in the last 3 months.
•Inability to comply with the protocol requirements.
•Inability to fill in the diary cards.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS

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Ferring SAS

Updated 1/4/2022