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
- Conditions
- Patients with mild to moderate ulcerative colitis
- Registration Number
- EUCTR2008-000045-59-BE
- Lead Sponsor
- Ferring SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 398
- Age 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 on the 7 days before inclusion and according to 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-mecraptopurine (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
- proctitits (less than 12-18 cm from the anorectal junction
- previous colonic surgery.
- previous failed to respond to steroids within the previous year.
- Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at dose > 3/day for induction of remission within the previous year.
- Current relapse lasting more than 6 weeks (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
(metronidazole) and ciproflocacin): 1 week wash-out.
* Oral steroids: 4 weeks wash-out.
* Rectal steroids: 2 weeks wash-out
* Repeated treatment (> 3 days of use) of non-steroidal anti-inflammatory drugs
(NSAID) oral or rectal route: 1 week wash-out (aspirin for cardioprotection is allowed.
* Sulfasalzine > 4g 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
weeks wash-out.
* Immunomodulating/suppressing drugs: 3 month for wash-out (except for
patients maintained on azathioprine or 6-mercaptopuring-see above)
- Known significant hepatic or renal function abnormalities.
- Moderate/severe abnormal renal, hepatic or blood count tests defineda 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 > 3 x 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