Budesonide for Maintenance Treatment of Collagenous Colitis

Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180076

Enrollment

Registered

2005-09-16

Start date

2004-07-31

Completion date

2008-03-31

Last updated

2010-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Collagenous Colitis

Keywords

collagenous colitis, microscopic colitis, budesonide

Brief summary

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

Detailed description

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

Interventions

DRUGBudesonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* collagenous colitis * diarrhea * written informed consent

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Proportion of patients in clinical remission after 6 months	—

Secondary

Measure	Time frame
time to relapse	—
safety	—
quality of life	—
histological improvement	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026