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Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

Primary Purpose

Collagenous Colitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Budesonide
Mesalazine
Placebo
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Collagenous Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (main):

  • > 4 watery/soft stools on at least 4 days in the week prior to baseline
  • > 3 stools per day on average within the last 7 days prior to baseline
  • Symptoms (chronic watery diarrhea) for at least 3 months before baseline
  • Complete colonoscopy within the last 12 weeks before baseline
  • Histologically confirmed diagnosis of collagenous colitis

Exclusion Criteria:

  • Evidence of infectious diarrhea
  • Celiac disease
  • Endoscopic-histologic findings, which may have caused diarrhea
  • History of partial colonic resection
  • Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
  • Active colorectal cancer or a history of colorectal cancer
  • Severe co-morbidity substantially reducing life expectancy
  • Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN)
  • Abnormal renal function (Cystatin C > ULN)
  • Active peptic ulcer disease, local intestinal infection
  • Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
  • Hemorrhagic diathesis

Sites / Locations

  • Center of digestive diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Rate of clinical remission (<= 3 stools per day) after 8 weeks

Secondary Outcome Measures

Rate of clinical remission (<= 3 stools per day) after 2 weeks
Time to remission
Impact on stool consistency (watery/soft/solid)
Impact on abdominal pain
Impact on patient's general well-being
Effect on histopathology
Severity of diarrhea
QoL
PGA

Full Information

First Posted
March 20, 2007
Last Updated
May 16, 2014
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00450086
Brief Title
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
Official Title
Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules vs. Mesalazine Granules vs. Placebo for Patients With Collagenous Colitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (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 determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.
Detailed Description
This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collagenous Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
9 mg per day
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Intervention Description
3 g per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0 g per day
Primary Outcome Measure Information:
Title
Rate of clinical remission (<= 3 stools per day) after 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Rate of clinical remission (<= 3 stools per day) after 2 weeks
Time Frame
2 weeks
Title
Time to remission
Title
Impact on stool consistency (watery/soft/solid)
Time Frame
8 weeks
Title
Impact on abdominal pain
Time Frame
8 weeks
Title
Impact on patient's general well-being
Time Frame
8 weeks
Title
Effect on histopathology
Time Frame
8 weeks
Title
Severity of diarrhea
Time Frame
8 weeks
Title
QoL
Time Frame
8 weeks
Title
PGA
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 (main): > 4 watery/soft stools on at least 4 days in the week prior to baseline > 3 stools per day on average within the last 7 days prior to baseline Symptoms (chronic watery diarrhea) for at least 3 months before baseline Complete colonoscopy within the last 12 weeks before baseline Histologically confirmed diagnosis of collagenous colitis Exclusion Criteria: Evidence of infectious diarrhea Celiac disease Endoscopic-histologic findings, which may have caused diarrhea History of partial colonic resection Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract Active colorectal cancer or a history of colorectal cancer Severe co-morbidity substantially reducing life expectancy Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN) Abnormal renal function (Cystatin C > ULN) Active peptic ulcer disease, local intestinal infection Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured Hemorrhagic diathesis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Miehlke, Professor
Organizational Affiliation
Center for digestive diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of digestive diseases
City
Hamburg
ZIP/Postal Code
20249
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24440672
Citation
Miehlke S, Madisch A, Kupcinskas L, Petrauskas D, Bohm G, Marks HJ, Neumeyer M, Nathan T, Fernandez-Banares F, Greinwald R, Mohrbacher R, Vieth M, Bonderup OK; BUC-60/COC Study Group. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. Gastroenterology. 2014 May;146(5):1222-30.e1-2. doi: 10.1053/j.gastro.2014.01.019. Epub 2014 Jan 15.
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Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

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