Treatment of Microscopic Colitis

NCT ID: NCT00184171

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Budesonide

Budesonide 9mg

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

Budesonide 9 mg

bismuth

Bismuth mixture

Group Type EXPERIMENTAL

Bismuth

Intervention Type DRUG

Bismuth mixture

Fiber

Fiber preparation

Group Type SHAM_COMPARATOR

Fiber

Intervention Type DRUG

Fiber for control

Interventions

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Budesonide

Budesonide 9 mg

Intervention Type DRUG

Bismuth

Bismuth mixture

Intervention Type DRUG

Fiber

Fiber for control

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per G Farup, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

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Aust-Agder Sentralsjukehus

Arendal, , Norway

Site Status

Sykehuset Innlandet HF, Gjøvik

Gjøvik, , Norway

Site Status

Sykehuset Innlandet, HF, Hamar

Hamar, , Norway

Site Status

Sykehuset Innlandet HF, Lillehammer

Lillehammer, , Norway

Site Status

Helse NordMøre og Romsdal

Molde, , Norway

Site Status

Akershus Universitetssykehus

Nordbyhagen, , Norway

Site Status

Aker sykehus

Oslo, , Norway

Site Status

Rikshopitalet

Oslo, , Norway

Site Status

St. Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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SLV 01-07035

Identifier Type: -

Identifier Source: org_study_id

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