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Long-Term Treatment of Collagenous Colitis With Budesonide

NCT00139165 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-03-06

No results posted yet for this study

Summary

The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)

Conditions

  • Collagenous Colitis

Interventions

DRUG

Budesonide

Capsule. Oral 6 mg o.d. for 24 weeks

PROCEDURE

sigmoidoscopy

Sigmoidoscopy performed 2 times during the study period.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Bonderup, Ole K., M.D.

    lead INDIV

Principal Investigators

  • Ole K Bonderup, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2006-03-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00139165 on ClinicalTrials.gov