Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA

• Conditions: Mild moderate active ulcerative colitis; MedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative

• Registration Number: EUCTR2006-004230-32-IT
• Lead Sponsor: CHIESI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Screening visit -Male or female >18 or <70 years old. -Female patients surgically sterilised or in post-menopausal period from at least 12 months or prepared to practise a birth control from the screening up to 30 days from the last dose. -History of ulcerative colitis dated mote than 3 months. -Oral Mesalazine (if current therapy) at stable dose in the last 14 days at maximum dose of 3.2 g/day, or balsalazide 6.75 g/day, or salazine 2 g/day, sulfasalazine 3 g/day Randomisation visit -Endoscopic score > or equal 1, confirmation of active ulcerative colitis -DAI > or equal to 3 and <10 -Rectal bleeding score > or equal to 1 -Negative pregnancy test
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

Severe ulcerative colitis,toxic megacolon, infectiuos colitis, ischemic colitis, colitis induced by drugs or radiotherapy. -Crohn? s disease. -Major gastrointestinal surgery. -Peptic ulcer. -Non compensated diabetes mellitus. -Non controlled hypertension. -Hyperthyroidism. -Cancer. -Patients that have received investigational new drugs within the last 12 weeks. -Positive stool examination for parassites and ova. -Significant hepatic or renal impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified