Budesonide for Maintenance Treatment of Collagenous Colitis

Technische Universität Dresden

Status and phase: Completed; Phase 3

Conditions: Collagenous Colitis

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00180076

MIMIC

Details and patient eligibility

About

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

Full description

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

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind