Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Proctitis
Intervention: Budesonide 2 mg suppository (Drug); Budesonide 4 mg suppository (Drug); Mesalazine 1 g suppository (Drug); Budesonide 2 mg suppository/Mesalazine 1 g suppository (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Dr. Falk Pharma GmbH Official(s) and/or principal investigator(s): Wolfgang Kruis, Professor, Principal Investigator, Affiliation: Evang. Krankenhaus Kalk, Medical Department Britta Siegmund, Professor, Principal Investigator, Affiliation: Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
Overall contact: Ralf Mohrbacher, MSc, Phone: ++49-761-1514-0, Ext: 156, Email: mohrbacher@drfalkpharma.de
Summary
The purpose of this study is to investigate the efficacy and safety of budesonide
suppository for the treatment of acute ulcerative proctitis.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Resolution of clinical symptoms
Secondary outcome: Rate of clinical and endoscopic remissionRate of improvement Rate of patients with clinical remission Rate of patients with endoscopic remission
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Ralf Mohrbacher, MSc, Phone: ++49-761-1514-0, Ext: 156, Email: mohrbacher@drfalkpharma.de
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin, Berlin 12203, Germany; Recruiting Britta Siegmund, Professor, Phone: ++40 30 450514, Ext: 322, Email: britta.siegmund@charite.de Britta Siegmund, Professor, Principal Investigator
Evang. Krankenhaus Kalk, Medical Department, Cologne 51103, Germany; Recruiting Wolfgang Kruis, Professor, Phone: ++49 221 8289, Ext: 5289, Email: kruis@evkk.de Wolfgang Kruis, Professor, Principal Investigator
Additional Information
Starting date: September 2013
Last updated: February 9, 2015
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