Clinical trial NCT00737789 (phase 3, status: completed)
Conditions: ulcerative colitis
ICD codes: K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811
Drugs: mesalazine slow-release granules, mesalazine liquid enema
SMILES: NC1=CC(C(O)=O)=C(O)C=C1, NC1=CC(C(O)=O)=C(O)C=C1
Eligibility criteria:

        Inclusion Criteria:

        Patients will be included if they comply with the following inclusion criteria determined
        at baseline, prior to first drug administration:

          -  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 on the 15 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-mercaptopurine (taken for at least 6
             months at stable dose and continued at the same dose throughout the study) is
             permitted.

          -  Informed consent given.

        Exclusion Criteria:

        The patients will not be included in the study if one of the following exclusion criteria
        is fulfilled at baseline, prior to first drug administration:

          -  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-Amino Salicylic Acid (5-ASA) therapy or to oral 5-ASA therapy
             at a dose > 3g/day for induction of remission within the previous year.

          -  Current relapse lasting more than 6 weeks (for 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 weeks wash-out.

          -  Rectal steroids: 2 weeks 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 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-mercaptopurine -see above).

          -  Known significant hepatic or renal function abnormalities.

          -  Moderate/severe abnormal renal, hepatic or blood count tests defined as: creatinine
             plasma value > 1.5 x Upper Limit of Normal (ULN) or white blood cells < 3500/mm˄3 or >
             15000/mm˄3 or Platelets < 100000/mm˄3 or > 800000/mm˄3 or aspartate
             aminotransferase/alanine Aminotransferase (ASAT/ALAT) > 3 x ULN or Gamma glutamyl
             transpeptidase (GGT)/Alkaline Phosphatase's > 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.