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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Budesonide; Mesalamine

Criteria

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