Treatment of Microscopic Colitis

This study has been completed.

Sponsors and Collaborators:	Norwegian University of Science and Technology AstraZeneca
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00184171

Purpose

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

Condition	Intervention	Phase
Colitis	Drug: Budesonide Drug: Bismuth Drug: Fiber	Phase IV

Drug Information available for: Budesonide Bismuth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Symptoms: Stool frequency and consistency

Secondary Outcome Measures:

Histological findins in biopsies from colon

Estimated Enrollment:	168
Study Start Date:	November 2001
Study Completion Date:	September 2007
Estimated Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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 lymphcocytic colitis).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184171

Locations

Norway
St. Olavs Hospital
Trondheim, Norway, 7006
Rikshopitalet
Oslo, Norway
Aker sykehus
Oslo, Norway
Sykehuset Innlandet HF, Gjøvik
Gjovik, Norway, 2819
Aust-Agder Sentralsjukehus
Arendal, Norway
Sykehuset Innlandet, HF, Hamar
Hamar, Norway
Sykehuset Innlandet HF, Lillehammer
Lillehammer, Norway
Helse NordMøre og Romsdal
Molde, Norway
Akershus Universitetssykehus
Nordbyhagen, Norway

Sponsors and Collaborators

Norwegian University of Science and Technology

AstraZeneca

Investigators

Study Chair:

Per G Farup, PhD

Norwegian University of Science and Technology

More Information

Responsible Party:	Norwegian University of Science and Technology ( Norwegian University of Science and Technology )
Study ID Numbers:	SLV 01-07035
Study First Received:	September 10, 2005
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00184171
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Microscopic colitis
Drug treatment
Diarrhoea

Study placed in the following topic categories:

Colitis, Microscopic
Diarrhea
Gastrointestinal Diseases
Lymphocytic colitis
Colonic Diseases
Budesonide
Colitis, Collagenous

Collagenous colitis
Intestinal Diseases
Colitis, Lymphocytic
Bismuth
Digestive System Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Antacids
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009