NCT00180076

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

2.7 years

First QC Date

September 9, 2005

Last Update Submit

March 29, 2010

Conditions

Collagenous Colitis

Keywords

collagenous colitismicroscopic colitisbudesonide

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in clinical remission after 6 months

Secondary Outcomes (4)

  • time to relapse

  • safety

  • quality of life

  • histological improvement

Interventions

BudesonideDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • collagenous colitis
  • diarrhea
  • written informed consent

You may not qualify if:

  • infectious causes for diarrhea
  • other inflammatory bowel diseases
  • history of colonic surgery
  • celiac disease
  • malignancies
  • severe concomitant diseases
  • use of budesonide, steroids, mesalazine within the previous 2 weeks
  • known intolerance to budesonide
  • history of lack of response to budesonide
  • pregnancy,lactation
  • drug and/or alcohol abuse
  • lack of compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department I, Technical University Hospital

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Colitis, CollagenousColitis, Microscopic

Interventions

Budesonide

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Stephan Miehlke, Prof.

    Medical Department I, Technical University Hospital, Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2008

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

DE(1)