Ulcerative Colitis

Why is this study being conducted?

This study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

What are the main eligibility criteria?

Inclusion Criteria:

• Male and female patients, 18-75 years old
• suffering from ulcerative colitis for at least 6 months

Exclusion Criteria:

Patients will be excluded from the study if they:

• Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line)
• Patients with infectious colitis
• Evidence or history of toxic megacolon
• Severe anaemia, leucopaenia or granulocytopaenia
• Use of anti tumour necrosis factor alpha (anti-TNFα) agents in the last 3 months
• Patients diagnosed with type 1 diabetes
• Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency
• Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents

Important

If you are interested in participating in a clinical trial, please register and you will be contacted by the study coordinator or person involved with the specific trial you are interested in.

• Prior to your participation a physician will inform you about the process in detail and examine if you are eligible to take part in the study.
• If you are to participate all medication will be free.
• Of course you can terminate during the process any time.

References:

Trial information was taken from the following sites:

• http://www.clinicaltrials.gov/ct2/show/NCT00679380
• In ClinLife opinion the main facts were taken and centralized. ClinLife isn´t liable for defects or wrong translation.
• Official Title: Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC