Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure) MedDRA version: 9.1 Level: LLT Classification code 10024123 Term: Left-sided ulcerative (chronic) colitis
Conditions
Interventions
Trade Name: MEZAVANT
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Mesalazine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-
Trade Name: ASACOL
Phar
Sponsors
GIULIANI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent. 2.Non-pregnant female. If appropriate , urine-test performed prior randomization. 3.Outpatients, male or female, aged 18-75 years. 4.Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure). 5.Patients must have either newly diagnosed or relapsing mild to moderate ulcerative colitis (score of 4?10 inclusive on the UC-DAI, with a sigmoidoscopy score of ≥ 1 and a Physician?s Global Assessment [PGA] of ≤ 2). 6.Patients who are treated for a minimum of 7 days with a total daily dose of 5-ASA between 1.6 g and 2,4 g at the time of the randomization visit and who are still in acute phase at the time of the randomization visit. 7.Ability to understand and comply with study procedures and restrictions. 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: 1.Patients on maintenance therapy with 5-ASA doses of 2.4 g /day or who have initiated the treatment with 5-ASA less than 7 days prior randomization. 2.Patients who, in the previous 12 months, had experienced a disease activity unresponsive to a 12-week course with steroids (steroid refractoriness) and those patients in whom steroid dose tapering had been unsuccessful because they returned to be symptomatic (steroid dependence). 3.Patients treated with corticosteroids, oral and/or topical, for at least 28 days prior the screening visit or patients who likely will be treated with oral and/or topical corticosteroids during the study. 4.Patients treated with azathioprine or any immunosuppressant for at least 12 months prior the screening visit. 5.A history of current or recurrent disease, other than UC, that could interfere with the interpretation of the study results or affect absorption or disposition of the study drug. This includes: peptic ulceration and gastrointestinal bleeding, celiac disease, lactose intolerance, pancreatitis, Crohn?s disease or proctitis only (where the extent of inflammation ≤ 10 cm from the anus). 6.A history of colon surgery performed within the past 12 months prior to the first dose of study drug, with the exception of an appendectomy. 7.Patients with asthma, if ASA sensitive. 5-ASA compounds are contraindicated with history of sensitivity or allergic reaction to salicylates/aspirin or a suspected history of intolerance or hypersensitivity to the study drug (mesalazine or salicylates), and related drug, or any of the stated ingredients. 8.History of concurrent malignancy or evidence of dysplasia in the colon specimen. 9.Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including infections, or any medical disorder that may require treatment (e.g. renal or hepatic impairment) or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures. 10.Evidence or suspect of positive test for HIV, HBsAg, or HCV 11.Patients presenting poor reliability (e.g. alcohol or drug abuse, bad mental conditions). 12.Patients who used another investigational agent or who took part in a clinical trial within the last 90 days prior to baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the colonic/rectal intramucosal concentrations of 5-ASA, ensured by a total daily dose of 4.8 g of either oral 5-ASA MMx or Asacol for the time to remission, or, if the remission is not achieved, for a maximum period of 8 weeks, in patients with mild to moderate left-sided ulcerative colitis and in acute phase at the time of the randomization.;Secondary Objective: To evaluate the colonic/rectal intramucosal concentrations of N-acetyl-5-ASA ensured by a total daily dose of 4.8 g of either oral 5-ASA MMx or Asacol for the time to remission, or, if the remission is not achieved, for a maximum period of 8 weeks, in the study patient population. To compare the time to remission between the two treatment groups. To compare the use of corticosteroids as rescue medication between the two treatment groups. To assess the safety and tolerability of 5-ASA MMx 4.8 g/day in the treatment of Ulcerative Colitis.;Primary end point(s): The primary end-point is to evaluate the colonic/rectal intramucosal concentrations of 5-ASA ensured by a total daily dose of 4.8 g of either oral 5-ASA MMx or Asacol at the Time of Remission or at 8 weeks, if the Remission is not achieved, in patients with mild to moderate left-sided ulcerative colitis and in acute phase at the time of the randomization | — |
Countries
Italy
Outcome results
None listed