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Treatment of Microscopic Colitis

Primary Purpose

Colitis

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Budesonide
Bismuth
Fiber
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis focused on measuring Microscopic colitis, Drug treatment, Diarrhoea

Eligibility Criteria

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

Inclusion Criteria: Microscopic colitis verified with biopsies from the colon Symptoms to such an extent that treatment is indicated Age > 17 years Informed consent Exclusion Criteria: Previous treatment with any of the investigational drugs Patients treated with ketoconazole Pregnant and breast-feeding females

Sites / Locations

  • Aust-Agder Sentralsjukehus
  • Sykehuset Innlandet HF, Gjøvik
  • Sykehuset Innlandet, HF, Hamar
  • Sykehuset Innlandet HF, Lillehammer
  • Helse NordMøre og Romsdal
  • Akershus Universitetssykehus
  • Aker sykehus
  • Rikshopitalet
  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Budesonide

bismuth

Fiber

Arm Description

Budesonide 9mg

Bismuth mixture

Fiber preparation

Outcomes

Primary Outcome Measures

Symptoms: Stool frequency and consistency
September 2010: Patient's enrollment completed. Data analysis ongoing.

Secondary Outcome Measures

Histological findings in biopsies from colon
Patient's enrollment completed. Data analysis ongoing.

Full Information

First Posted
September 10, 2005
Last Updated
January 20, 2015
Sponsor
Norwegian University of Science and Technology
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00184171
Brief Title
Treatment of Microscopic Colitis
Official Title
Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
insufficient data quality
Study Start Date
November 2001 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis
Detailed Description
This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis
Keywords
Microscopic colitis, Drug treatment, Diarrhoea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide
Arm Type
Experimental
Arm Description
Budesonide 9mg
Arm Title
bismuth
Arm Type
Experimental
Arm Description
Bismuth mixture
Arm Title
Fiber
Arm Type
Sham Comparator
Arm Description
Fiber preparation
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
Budesonide 9 mg
Intervention Type
Drug
Intervention Name(s)
Bismuth
Intervention Description
Bismuth mixture
Intervention Type
Drug
Intervention Name(s)
Fiber
Intervention Description
Fiber for control
Primary Outcome Measure Information:
Title
Symptoms: Stool frequency and consistency
Description
September 2010: Patient's enrollment completed. Data analysis ongoing.
Time Frame
2001 - 2011
Secondary Outcome Measure Information:
Title
Histological findings in biopsies from colon
Description
Patient's enrollment completed. Data analysis ongoing.
Time Frame
2001 - 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Microscopic colitis verified with biopsies from the colon Symptoms to such an extent that treatment is indicated Age > 17 years Informed consent Exclusion Criteria: Previous treatment with any of the investigational drugs Patients treated with ketoconazole Pregnant and breast-feeding females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per G Farup, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Aust-Agder Sentralsjukehus
City
Arendal
Country
Norway
Facility Name
Sykehuset Innlandet HF, Gjøvik
City
Gjovik
ZIP/Postal Code
2819
Country
Norway
Facility Name
Sykehuset Innlandet, HF, Hamar
City
Hamar
Country
Norway
Facility Name
Sykehuset Innlandet HF, Lillehammer
City
Lillehammer
Country
Norway
Facility Name
Helse NordMøre og Romsdal
City
Molde
Country
Norway
Facility Name
Akershus Universitetssykehus
City
Nordbyhagen
Country
Norway
Facility Name
Aker sykehus
City
Oslo
Country
Norway
Facility Name
Rikshopitalet
City
Oslo
Country
Norway
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Treatment of Microscopic Colitis

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