Overview

This trial is active, not recruiting.

Conditions ulcerative colitis, large intestine, diarrhea, abdominal pain
Treatments lt-02, placebo
Phase phase 2
Sponsor Lipid Therapeutics GmbH
Start date December 2009
End date July 2011
Trial size 156 participants
Trial identifier NCT01011322, 2008-007952-90, LT-02-UC-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
0.2g IMP per dose
lt-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
(Experimental)
0.4g IMP per dose
lt-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
(Experimental)
0.8g IMP per dose
lt-02
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
(Placebo Comparator)
placebo matching to 0g of IMP,
placebo
placebo

Primary Outcomes

Measure
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
time frame: From day 1 of treatment until end of treatment

Secondary Outcomes

Measure
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
time frame: After study is completed

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Men and women 18 years or older who have given written Informed Consent - Patients with proven ulcerative colitis - Active disease course for the last 6 weeks or longer with bloody diarrhea - Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine. Exclusion Criteria: - Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis, - Crohn's disease, - Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis, - Treatment with other investigational medicinal product within 3 months prior to study entry

Additional Information

Principal investigator Max Karner, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Lipid Therapeutics GmbH.