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Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease

NCT01624376 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-02-04

No results posted yet for this study

Summary

The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.

The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after the last study visit.

Conditions

  • Fistulizing Crohn's Disease

Interventions

DRUG

DLX105

10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.

DRUG

Placebo

Placebo injections are administered over the treatment period of 4 weeks.

Sponsors & Collaborators

  • Delenex Therapeutics AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-02-28
Completion
2013-08-31

Countries

  • Switzerland

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 NCT01624376 on ClinicalTrials.gov