Patients with mild to moderate ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10058816 Term: Colitis ulcerative acute episode
Conditions
Interventions
Product Name: Pentasa 2g sachet prolonged release granules (95%)
Pharmaceutical Form: Granules
INN or Proposed INN: MESALAZINE
CAS Number: 89576
Concentration unit: g gram(s)
Concentration type: equal
Sponsors
Ferring SAS
Eligibility
Sex/Gender
All
Inclusion criteria
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 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-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
Exclusion criteria: •Proctitis (less than12-18 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 a 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 ciprofloxacin): 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 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-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 ULN or white blood cells 15000/mm3 or platelets 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that mesalazine po 4g per day once daily (QD.) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID.) (2g x 2 per day), in patients with active ulcerative colitis treated for 8 weeks, in terms of remission evaluated with the UC-DAI score and defined as ? 1. Both groups (4g QD and 2gx2) will receive an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.;Secondary Objective: •Compliance •Clinical remission at week 4 and week 8 •Clinical variables improvement (stools frequency and blood stools) at week 4, 8 and 12 separately •Treatment failure rates at W4 and W8 •Time to remission according patient’s diary (normal stools frequency and cessation of bleeding) •Time to cessation of bleeding •Improvement at week 4 and 8 based on UC-DAI score •Endoscopic assessment at W0 and W8 •Acceptability of the treatment •Safety •Proportion of patients staying in clinical remission at week 12. ;Primary end point(s): •Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score =1. •Secondary efficacy variables oCompliance at W8 oClinical remission at week 4, 8 and 12 oTreatment failure rates at W4 and W8 defined as the need for other treatment than those allowed by the protocol. Treatment failure will be counted as non-remission oClinical variables (Stool frequency and bloody stools) at week 4, 8 and 12 separatly oTime of cessation of bleeding oTime to remission according patient’s diary (normal stools frequency and cessation of bleeding) oImprovement at week 4 and week 8 based on UC-DAI score oEndoscopic assessment at week 0 and at week 8 oAcceptability of the treatment at W4 and W8 oSafety | — |
Countries
Belgium, France, Netherlands, United Kingdom
Outcome results
None listed