Treatment of Microscopic Colitis

Colitis Clinical Trial

Official title:

Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00184171
• Other study ID #: SLV 01-07035
• Status: Terminated
• Phase: N/A
• First received: September 10, 2005
• Last updated: January 20, 2015
• Start date: November 2001
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: October 2014
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic

Intervention

Drug:
• Budesonide
Budesonide 9 mg
• Bismuth
Bismuth mixture
• Fiber
Fiber for control

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	AstraZeneca

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms: Stool frequency and consistency	September 2010: Patient's enrollment completed. Data analysis ongoing.	2001 - 2011	No
Secondary	Histological findings in biopsies from colon	Patient's enrollment completed. Data analysis ongoing.	2001 - 2011	No