NCT01966783

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Proctitis

Interventions

Type	Name	Description
DRUG	Budesonide 2 mg suppository	per day
DRUG	Budesonide 4 mg suppository	per day
DRUG	Mesalazine 1 g suppository	per day
DRUG	Budesonide 2 mg suppository/Mesalazine 1 g suppository	per day

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-10-22
• Last updated: 2019-05-07

Locations

2 sites across 1 country: Germany