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SOIBD Collagenous Colitis Maintenance Study

NCT01278082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2016-01-21

No results posted yet for this study

Summary

This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period

Conditions

  • Induction and Maintaining Remission of Collagenous Colitis

Interventions

DRUG

Budesonide

Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day

DRUG

Placebo

Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.

Sponsors & Collaborators

  • The Swedish Organization for Studies on Inflammatory Bowel Disease

    collaborator OTHER

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Ralph Müller, Dr · Dr. Falk Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-03-31
Completion
2013-09-30

Countries

  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01278082 on ClinicalTrials.gov