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.

Study Overview

• Status: Completed
• Conditions: Proctitis
• Intervention / Treatment: Drug: Budesonide 2 mg suppository; Drug: Budesonide 4 mg suppository; Drug: Mesalazine 1 g suppository; Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
  • Cologne, Germany, 51103
    • Evang. Krankenhaus Kalk, Medical department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Budesonide dosage 1; Budesonide 2 mg suppository	Drug: Budesonide 2 mg suppository; per day
Experimental: Budesonide dosage 2; Budesonide 4 mg suppository	Drug: Budesonide 4 mg suppository; per day
Active Comparator: Mesalazine; Mesalazine 1g suppository	Drug: Mesalazine 1 g suppository; per day
Experimental: Combination; Budesonide 2 mg suppository/Mesalazine 1 g suppository	Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository; per day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Falk Pharma GmbH
• Investigators: Principal Investigator: Wolfgang Kruis, Professor, Evang. Krankenhaus Kalk, Medical department; Principal Investigator: Britta Siegmund, Professor, Charité-Campus Benjamin Franklin Universitätsmedizin Berlin

Publications and helpful links

General Publications

• Kruis W, Neshta V, Pesegova M, Alekseeva O, Andreev P, Datsenko O, Levchenko O, Abdulkhakov S, Lozynskyy Y, Mostovoy Y, Soloviev K, Dorofeyev AE, Vieth M, Stiess M, Greinwald R, Mohrbacher R, Siegmund B. Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):98-106.e4. doi: 10.1016/j.cgh.2018.04.027. Epub 2018 Apr 24.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Rectal Diseases; Proctitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide; Mesalamine
• Other Study ID Numbers: BUS-2/UCA; 2012-003362-41 (EudraCT Number)