NCT00139165

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

March 6, 2008

Status Verified

August 1, 2005

First QC Date

August 29, 2005

Last Update Submit

March 3, 2008

Conditions

Collagenous Colitis

Keywords

Collagenous colitisBudesonide treatmentDiarrhea

Outcome Measures

Primary Outcomes (1)

  • Clinical symptoms

Secondary Outcomes (1)

  • Histological changes

Interventions

BudesonideDRUG

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

sigmoidoscopyPROCEDURE

Sigmoidoscopy performed 2 times during the study period.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological criteria of Collagenous colitis
  • Clinical activity (\> 3 stools/day)

You may not qualify if:

  • Treatment of Collagenous colitis within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of medical gastroenterology

Aalborg, 9100, Denmark

Location

Dept. of medical gastroenterology

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Colitis, CollagenousDiarrhea

Interventions

BudesonideSigmoidoscopy

Condition Hierarchy (Ancestors)

Colitis, MicroscopicColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsColonoscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Ole K Bonderup, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

September 1, 2004

Study Completion

March 1, 2006

Last Updated

March 6, 2008

Record last verified: 2005-08

Locations

DK(2)