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: July 25, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Symptoms: Stool frequency and consistency [ Time Frame: 2001 - 2011 ] [ Designated as safety issue: No ]
    September 2010: Patient's enrollment completed. Data analysis ongoing.


Secondary Outcome Measures:
  • Histological findings in biopsies from colon [ Time Frame: 2001 - 2011 ] [ Designated as safety issue: No ]
    Patient's enrollment completed. Data analysis ongoing.


Estimated Enrollment: 120
Study Start Date: November 2001
Estimated Study Completion Date: October 2014
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide
Budesonide 9mg
Drug: Budesonide
Budesonide 9 mg
Experimental: bismuth
Bismuth mixture
Drug: Bismuth
Bismuth mixture
Sham Comparator: Fiber
Fiber preparation
Drug: Fiber
Fiber for control

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184171     History of Changes
Other Study ID Numbers: SLV 01-07035
Study First Received: September 10, 2005
Last Updated: July 25, 2014
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Microscopic colitis
Drug treatment
Diarrhoea

Additional relevant MeSH terms:
Colitis
Colitis, Microscopic
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Bismuth
Budesonide
Antacids
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014