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A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis

NCT01011322 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2011-11-16

No results posted yet for this study

Summary

The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.

Conditions

Interventions

DRUG

LT-02

Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks

DRUG

placebo

placebo

Sponsors & Collaborators

  • Lipid Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Max Karner, MD · University Clinic Heidelberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-07-31
Completion
2012-02-29

Countries

  • Germany
  • Lithuania
  • Romania

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01011322 on ClinicalTrials.gov