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Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

NCT01966783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2019-05-07

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

Conditions

  • Proctitis

Interventions

DRUG

Budesonide 2 mg suppository

per day

DRUG

Budesonide 4 mg suppository

per day

DRUG

Mesalazine 1 g suppository

per day

DRUG

Budesonide 2 mg suppository/Mesalazine 1 g suppository

per day

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Wolfgang Kruis, Professor · Evang. Krankenhaus Kalk, Medical Department

  • Britta Siegmund, Professor · Charité-Campus Benjamin Franklin Universitätsmedizin Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Germany

Study Locations

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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 NCT01966783 on ClinicalTrials.gov