Long-Term Treatment of Collagenous Colitis With Budesonide

Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139165

Enrollment

Registered

2005-08-31

Start date

2004-09-30

Completion date

2006-03-31

Last updated

2008-03-06

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, Budesonide treatment, Diarrhea

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)

Interventions

DRUGBudesonide

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

PROCEDUREsigmoidoscopy

Sigmoidoscopy performed 2 times during the study period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Treatment of Collagenous colitis within the last 3 months

Design outcomes

Primary

Measure	Time frame
Clinical symptoms	—

Secondary

Measure	Time frame
Histological changes	—

Countries

Denmark

Outcome results

None listed

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