Back to resultsBudesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
Primary Purpose
Proctitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Budesonide 2 mg suppository
Budesonide 4 mg suppository
Mesalazine 1 g suppository
Budesonide 2 mg suppository/Mesalazine 1 g suppository
Sponsored by
About this trial
This is an interventional treatment trial for Proctitis
Eligibility 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
Sites / Locations
- Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
- Evang. Krankenhaus Kalk, Medical Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Arm Label
Budesonide dosage 1
Budesonide dosage 2
Mesalazine
Combination
Arm Description
Budesonide 2 mg suppository
Budesonide 4 mg suppository
Mesalazine 1g suppository
Budesonide 2 mg suppository/Mesalazine 1 g suppository
Outcomes
Primary Outcome Measures
Resolution of clinical symptoms
Symptoms as reported in the diary
Secondary Outcome Measures
Rate of clinical and endoscopic remission
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Rate of improvement
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Rate of patients with clinical remission
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Rate of patients with endoscopic remission
Ulcerative colitis-disease activity index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01966783
Brief Title
Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proctitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Budesonide dosage 1
Arm Type
Experimental
Arm Description
Budesonide 2 mg suppository
Arm Title
Budesonide dosage 2
Arm Type
Experimental
Arm Description
Budesonide 4 mg suppository
Arm Title
Mesalazine
Arm Type
Active Comparator
Arm Description
Mesalazine 1g suppository
Arm Title
Combination
Arm Type
Experimental
Arm Description
Budesonide 2 mg suppository/Mesalazine 1 g suppository
Intervention Type
Drug
Intervention Name(s)
Budesonide 2 mg suppository
Intervention Description
per day
Intervention Type
Drug
Intervention Name(s)
Budesonide 4 mg suppository
Intervention Description
per day
Intervention Type
Drug
Intervention Name(s)
Mesalazine 1 g suppository
Intervention Description
per day
Intervention Type
Drug
Intervention Name(s)
Budesonide 2 mg suppository/Mesalazine 1 g suppository
Intervention Description
per day
Primary Outcome Measure Information:
Title
Resolution of clinical symptoms
Description
Symptoms as reported in the diary
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Rate of clinical and endoscopic remission
Description
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Time Frame
8 weeks
Title
Rate of improvement
Description
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Time Frame
8 weeks
Title
Rate of patients with clinical remission
Description
Symptoms as reported in the diary, ulcerative colitis-disease activity index
Time Frame
8 weeks
Title
Rate of patients with endoscopic remission
Description
Ulcerative colitis-disease activity index
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kruis, Professor
Organizational Affiliation
Evang. Krankenhaus Kalk, Medical Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Britta Siegmund, Professor
Organizational Affiliation
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité-Campus Benjamin Franklin Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Evang. Krankenhaus Kalk, Medical Department
City
Cologne
ZIP/Postal Code
51103
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29702300
Citation
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.
Results Reference
result
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Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
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