Moderate active Crohn disease
Conditions
Interventions
Product Name: Mesalazine EC 500 mg
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: mesalazine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
Disphar International B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this trial, patients will have to meet all of the following criteria: - established diagnosis of Crohn disease in Moderate active status verified by clinical evaluation, laboratory tests and by X-ray examination or/and colonoscopy and histology - Crohn disease of at least 3 months duration - acute exacerbation of moderate Crohn disease with a CDAI score between 220–400 points - patients between 18–75 years, both sexes - written informed consent obtained 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: Patients meeting any of the following criteria will be excluded from participation in this study: -positive stool culture for enteric pathogens including Salmonella, Shigella, Yersinia or Campylobacter -pregnant or lactating women -women of child bearing potential not taking adequate contraceptive precautions -maintenance treatment with higher daily doses (orally or rectally) than 4 g of Sulfasalazine or 2 g of Mesalazine EC 500 mg or any derivative up to one month before entering the study -chronic use of any anti-inflammatory drugs, including NSAID´s (rectally or orally) within 7 days prior to inclusion; chronic use is defined as intake of medication every day for more than 7 consecutive days -chronic administration of any steroids is an exclusion criterion within 7 days before entering the study -chronic administration of any immunosuppressive agents is an exclusion criterion within 3 months before entering the study -any other disease or condition which may interfere with study assessments as judged by the investigator -alcohol or drug abuse -patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months -patients allergic to aspirin or other salicylates -clinically significant renal/hepatic impairment or serious heartdisease -patients presenting any malignant disease -patients likely not to comply with the study procedures -patients with any kind of stomy and after subtotal colectomy and with ileorectal anastomosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the study drug (Mesalazine EC tablets 500 mg) is at least as effective (non-inferiority testing) as the comparative medication (Salofalk® tablets 500 mg) in the common dose regimen 3× 3 tbl (= 4.5 g/daily) based on remission rate in both groups. ;Secondary Objective: To determine the safety and tolerability of Mesalazine EC tablets 500 mg.;Primary end point(s): Proportions of patients considered to have achieved clinical remission (final CDAI score < 150 points). | — |
Countries
Czech Republic
Outcome results
None listed