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

Phase 2

Completed

• Conditions: Proctitis
• Interventions: Drug: Budesonide 2 mg suppository; Drug: Budesonide 4 mg suppository; Drug: Mesalazine 1 g suppository; Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository

• Registration Number: NCT01966783
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-22
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide dosage 1	Budesonide 2 mg suppository	Budesonide 2 mg suppository
Budesonide dosage 2	Budesonide 4 mg suppository	Budesonide 4 mg suppository
Mesalazine	Mesalazine 1 g suppository	Mesalazine 1g suppository
Combination	Budesonide 2 mg suppository/Mesalazine 1 g suppository	Budesonide 2 mg suppository/Mesalazine 1 g suppository

Primary Outcome Measures

Name	Time	Method
Resolution of clinical symptoms	8 weeks	Symptoms as reported in the diary

Secondary Outcome Measures

Name	Time	Method
Rate of patients with clinical remission	8 weeks	Symptoms as reported in the diary, ulcerative colitis-disease activity index
Rate of clinical and endoscopic remission	8 weeks	Symptoms as reported in the diary, ulcerative colitis-disease activity index
Rate of improvement	8 weeks	Symptoms as reported in the diary, ulcerative colitis-disease activity index
Rate of patients with endoscopic remission	8 weeks	Ulcerative colitis-disease activity index

Trial Locations

Locations (2)

Charité-Campus Benjamin Franklin Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Evang. Krankenhaus Kalk, Medical Department; 🇩🇪 Cologne, Germany