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

Study Overview

• Status: Terminated
• Conditions: Colitis
• Intervention / Treatment: Drug: Budesonide; Drug: Bismuth; Drug: Fiber

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).

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms: Stool frequency and consistency	September 2010: Patient's enrollment completed. Data analysis ongoing.	2001 - 2011

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological findings in biopsies from colon	Patient's enrollment completed. Data analysis ongoing.	2001 - 2011

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: AstraZeneca
• Investigators: Study Chair: Per G Farup, PhD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 10, 2005
• First Submitted That Met QC Criteria: September 15, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Microscopic colitis; Drug treatment; Diarrhoea
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Colitis; Colitis, Microscopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antacids; Budesonide; Bismuth
• Other Study ID Numbers: SLV 01-07035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No