Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patients With Acute Ulcerative Proctitis

The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

Inclusion Criteria:

• Active ulcerative proctitis
• Diagnosis confirmed by endoscopy
• Established disease or new diagnosis

Exclusion Criteria:

• Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis
• Presence of proctitis of a different origin
• Prior bowel resection
• Presence of symptomatic organic disease of the gastrointestinal tract
• Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured
• Local intestinal infection
• Abnormal hepatic or renal function
• Oral/rectal/intravenous corticosteroids therapy
• Existing or intended pregnancy or breast-feeding
• Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial