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

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

Official Title
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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

Conditions
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Proctitis

Intervention / Treatment
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* Drug: Budesonide 2 mg suppository
* Drug: Budesonide 4 mg suppository
* Drug: Mesalazine 1 g suppository
* Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide dosage 1<br>Budesonide 2 mg suppository | Drug: Budesonide 2 mg suppository<br>* per day<br>|
| Experimental: Budesonide dosage 2<br>Budesonide 4 mg suppository | Drug: Budesonide 4 mg suppository<br>* per day<br>|
| Active Comparator: Mesalazine<br>Mesalazine 1g suppository | Drug: Mesalazine 1 g suppository<br>* per day<br>|
| Experimental: Combination<br>Budesonide 2 mg suppository/Mesalazine 1 g suppository | Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository<br>* per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of clinical symptoms | Symptoms as reported in the diary | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical and endoscopic remission | Symptoms as reported in the diary, ulcerative colitis-disease activity index | 8 weeks | 
| Rate of improvement | Symptoms as reported in the diary, ulcerative colitis-disease activity index | 8 weeks | 
| Rate of patients with clinical remission | Symptoms as reported in the diary, ulcerative colitis-disease activity index | 8 weeks | 
| Rate of patients with endoscopic remission | Ulcerative colitis-disease activity index | 8 weeks |