Trial | NCT00139165  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    budesonide ...

  • Study Participants

    36
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)
Study Started
Sep 30
2004
Study Completion
Mar 31
2006
Last Update
Mar 06
2008
Estimate

Drug Budesonide

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

Procedure sigmoidoscopy

Sigmoidoscopy performed 2 times during the study period.

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Treatment of Collagenous colitis within the last 3 months
No Results Posted