Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
NCT ID: NCT01966783
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
320 participants
INTERVENTIONAL
2013-09-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Budesonide dosage 1
Budesonide 2 mg suppository
Budesonide 2 mg suppository
per day
Budesonide dosage 2
Budesonide 4 mg suppository
Budesonide 4 mg suppository
per day
Mesalazine
Mesalazine 1g suppository
Mesalazine 1 g suppository
per day
Combination
Budesonide 2 mg suppository/Mesalazine 1 g suppository
Budesonide 2 mg suppository/Mesalazine 1 g suppository
per day
Interventions
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Budesonide 2 mg suppository
per day
Budesonide 4 mg suppository
per day
Mesalazine 1 g suppository
per day
Budesonide 2 mg suppository/Mesalazine 1 g suppository
per day
Eligibility Criteria
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Inclusion Criteria
* Diagnosis confirmed by endoscopy
* Established disease or new diagnosis
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Wolfgang Kruis, Professor
Role: PRINCIPAL_INVESTIGATOR
Evang. Krankenhaus Kalk, Medical Department
Britta Siegmund, Professor
Role: PRINCIPAL_INVESTIGATOR
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
Locations
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Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
Berlin, , Germany
Evang. Krankenhaus Kalk, Medical Department
Cologne, , Germany
Countries
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References
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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.
Other Identifiers
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2012-003362-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BUS-2/UCA
Identifier Type: -
Identifier Source: org_study_id
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