Treatment of Microscopic Colitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184171
First received: September 10, 2005
Last updated: November 18, 2013
Last verified: November 2013

September 10, 2005
November 18, 2013
November 2001
September 2010   (final data collection date for primary outcome measure)
Symptoms: Stool frequency and consistency [ Time Frame: 2001 - 2011 ] [ Designated as safety issue: No ]
September 2010: Patient's enrollment completed. Data analysis ongoing.
Symptoms: Stool frequency and consistency
Complete list of historical versions of study NCT00184171 on ClinicalTrials.gov Archive Site
Histological findings in biopsies from colon [ Time Frame: 2001 - 2011 ] [ Designated as safety issue: No ]
Patient's enrollment completed. Data analysis ongoing.
Histological findins in biopsies from colon
Not Provided
Not Provided
 
Treatment of Microscopic Colitis
Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber

The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colitis
  • Drug: Budesonide
    Budesonide 9 mg
  • Drug: Bismuth
    Bismuth mixture
  • Drug: Fiber
    Fiber for control
  • Experimental: Budesonide
    Budesonide 9mg
    Intervention: Drug: Budesonide
  • Experimental: bismuth
    Bismuth mixture
    Intervention: Drug: Bismuth
  • Sham Comparator: Fiber
    Fiber preparation
    Intervention: Drug: Fiber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
April 2014
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00184171
SLV 01-07035
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
AstraZeneca
Study Chair: Per G Farup, PhD Norwegian University of Science and Technology
Norwegian University of Science and Technology
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP