NCT00180050

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2002

Longer than P75 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

January 1, 2002

Completed
3.7 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

4.6 years

First QC Date

September 9, 2005

Last Update Submit

March 29, 2010

Conditions

Microscopic Colitis

Keywords

lymphocytic colitismicroscopic colitisbudesonide

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in clinical remission after 6 weeks

Secondary Outcomes (3)

  • 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:

  • lymphocytic colitis
  • diarrhea
  • effective contraception
  • written informed consent

You may not qualify if:

  • other forms if IBD
  • celiac disease
  • infectious colitis
  • history of colonic surgery
  • use of budesonide, 5-ASA, steroids within th previous 4 weeks
  • pregnancy, lactation

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, MicroscopicColitis, Lymphocytic

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

January 1, 2002

Primary Completion

August 1, 2006

Study Completion

August 1, 2007

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

DE(1)