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Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease

NCT01279577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2015-02-10

No results posted yet for this study

Summary

This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.

This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.

Conditions

  • Crohn´s Disease

Interventions

DRUG

Low dose TSO

Low dose TSO suspension

DRUG

Medium dose TSO

Medium dose TSO suspension

DRUG

High dose TSO

High dose TSO suspension

DRUG

Placebo

Placebo solution

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Jürgen Schölmerich, Prof. · Klinikum der Johann Wolfgang Goethe-Universität

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
2010-11-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Germany

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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 NCT01279577 on ClinicalTrials.gov