Long-Term Treatment of Collagenous Colitis With Budesonide

Bonderup, Ole K., M.D.

Status and phase: Unknown; Phase 3

Conditions: Collagenous Colitis

Treatments: Drug: Budesonide; Procedure: sigmoidoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139165

okbon123

Details and patient eligibility

About

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)

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind