Back to resultsBudesonide for Induction of Remission in Incomplete Microscopic Colitis
Primary Purpose
Incomplete Microscopic Colitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide granules 9 mg
Placebo granules
Sponsored by
About this trial
This is an interventional treatment trial for Incomplete Microscopic Colitis
Eligibility Criteria
Inclusion Criteria:
- Histologically established diagnosis of incomplete microscopic colitis (MCi)
- History of chronic non-bloody, watery diarrhoea
- Clinically active disease
Exclusion Criteria:
- Other significant abnormalities in colonoscopy
- Infectious cause of diarrhoea
- Clinical suspicion of drug-induced diarrhoea
- Prior and present MC
- History of bowel resection
- Radiation therapy of the abdominal or pelvic region
- Positive antibody titres for celiac disease
- Untreated active thyroid dysfunction
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
- Abnormal hepatic function
- Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
- History of colorectal cancer
- History of cancer (other than colorectal) in the last 5 years
- Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
- Current or intended pregnancy or breast-feeding
- Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Sites / Locations
- Centre for Digestive Diseases
- University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Budesonide granules 9 mg
Placebo granules
Outcomes
Primary Outcome Measures
Rate of clinical remission
Secondary Outcome Measures
Rate of clinical remission
Rate of clinical remission
Time to remission
Number of formed/soft/watery stools per week
Number of days with abdominal pain
Number of days with urgency
Rate of histological remission
Physician's global assessment at final visit
Quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02142634
Brief Title
Budesonide for Induction of Remission in Incomplete Microscopic Colitis
Official Title
Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Microscopic Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Budesonide granules 9 mg
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo granules
Intervention Type
Drug
Intervention Name(s)
Budesonide granules 9 mg
Intervention Description
per day
Intervention Type
Drug
Intervention Name(s)
Placebo granules
Intervention Description
per day
Primary Outcome Measure Information:
Title
Rate of clinical remission
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Rate of clinical remission
Time Frame
2 weeks
Title
Rate of clinical remission
Time Frame
6 weeks
Title
Time to remission
Time Frame
8 weeks
Title
Number of formed/soft/watery stools per week
Time Frame
8 weeks
Title
Number of days with abdominal pain
Time Frame
8 weeks
Title
Number of days with urgency
Time Frame
8 weeks
Title
Rate of histological remission
Time Frame
8 weeks
Title
Physician's global assessment at final visit
Time Frame
8 weeks
Title
Quality of life
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically established diagnosis of incomplete microscopic colitis (MCi)
History of chronic non-bloody, watery diarrhoea
Clinically active disease
Exclusion Criteria:
Other significant abnormalities in colonoscopy
Infectious cause of diarrhoea
Clinical suspicion of drug-induced diarrhoea
Prior and present MC
History of bowel resection
Radiation therapy of the abdominal or pelvic region
Positive antibody titres for celiac disease
Untreated active thyroid dysfunction
Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
Abnormal hepatic function
Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
History of colorectal cancer
History of cancer (other than colorectal) in the last 5 years
Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
Current or intended pregnancy or breast-feeding
Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
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
Andreas Münch, MD
Organizational Affiliation
University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Digestive Diseases
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Budesonide for Induction of Remission in Incomplete Microscopic Colitis
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