EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study
- Conditions
- lcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examinationMedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis
- Registration Number
- EUCTR2006-004230-32-PL
- Lead Sponsor
- Chiesi Farmaceutici SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Pre-inclusion criteria at screening visit:
- male or female = 18 and = 70 years old;
- women of child-bearing potential using effective contraceptive methods;
- history and documented diagnosis of ulcerative colitis, dated from more than 3 months;
Rectal bleeding score = 1;
- Stable dosage of ongoing oral mesalazine therapy (maximum dosage 3.2 g/day) For patients under treatment with other oral medication containing 5 ASA maximum allowed dosage at study entry is: balsalazide (6.7 g/day), or olsalazine (2 g/day) or sulfasalazine (3 g/day) in the last 14 days;
- Able to understand and to follow the protocol;
- Having given written informed consent for study participation;
Inclusion criteria at randomization (end of run-in period)
- Endoscopic score = 1 in one or more colon segments;
- DAI score = 3 and < 10;
- Confirmation of rectal bleeding score = 1;
- Negative stool examination for infectious disease;
- Absence of concomitant medications since the screening visit (especially for non authorized treatments);
- Negative pregnancy test for women
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 at screening:
- Women of childbearing potential not using adequate contraceptive methods;
- Pregnant women or breast-feeding women;
- Severe ulcerative colitis or toxic megacolon;
- Infectious Colitis;
- Ischemic Colitis;
- Colitis induced by drug or radiotherapy;
- Chron's disease;
- Major gastro-intestinal surgery other than appendectomy;
- Evolutive active peptic ulcer or medical history of peptic ulcer complications;
- Non compensated diabetes mellitus;
- Non controlled arterial hypertension (SBP = 160 mm Hg and or DBP = 100 mm Hg)
- Hyperthyroidism;
- Medical history of concomitant cancer or other disease which, according to Investgators' opinion could interfere with the evaluation of the test drug;
- Poorly controlled pulmonary infections (tubercolosis, active mycotic infections);
- Patients receiving oral or injectable corticosteroids (oral budesonide included) within 30 days from screening visit, rectal corticosteroids (suppositories, enema, foams), inhaled corticosteroids in the 14 days prior to screening visit;
- Change in the dose of oral Mesalazine treatment, in the 14 days prior the screening visit or at a dosage superior to 3.2 g/day or balsalazide (6.7 g/day), olsalazine (2 g/day), or sulfasalazine (3 g/day);
- Patients being treated with H2-receptor antagonists or proton pump inhibitor (PPIs) in the previous 2 weeks ;
- Use of immunomodulators or immunodepressants in the previous 3 months;
- Patients treated with TNF-alfa antagonists in the previous 6 months;
- Antibiotic treatment that cannot be stopped before randomization;
- History of drug or alcohol abuse;
- Patients who took part to another trial in the previous 3 months-
Exclusion criteria at randomization (end of run-in period)
- Severe ulcerative colitis (DAI > 10);
- Positive ova and parasitic stool examination;
- Ulcerative Colitis with endoscopic store < 1 or rectal bleeding score < 1;
- Ulcerative Colitis limited to the rectum;
- Chron's Disease;
- Significant hepatic impairment (AST or ALT twice the upper limit of normal range);
- Significant renal impairment (sreum creatinine > 1.5 mg/dL);
- Any abnormal laboratory test which could interfere with the protocol
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