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

Sponsor

Lipid Therapeutics GmbH (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01011322

Collaborator

(none)

156

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Large Intestine Diarrhea Abdominal Pain	Drug: LT-02 Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LT-02 Dose 1 0.2g IMP per dose	Drug: LT-02 Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
Experimental: LT-02 Dose 2 0.4g IMP per dose	Drug: LT-02 Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
Experimental: LT-02 Dose 3 0.8g IMP per dose	Drug: LT-02 Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
Placebo Comparator: Sugar pill placebo matching to 0g of IMP,	Drug: placebo placebo

Outcome Measures

Primary Outcome Measures

To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis [From day 1 of treatment until end of treatment]

Secondary Outcome Measures

To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis [After study is completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterologische Praxis	Baden-Baden	Baden-Wuerttemberg	Germany	76530
2	University Clinic Heidelberg	Heidelberg	Baden-Wuerttemberg	Germany	69120
3	Robert-Bosch-Krankenhaus	Stuttgart	Baden-Wuerttemberg	Germany
4	Universitaetsklinikum Ulm	Ulm	Baden-Wuerttemberg	Germany	89070
5	Interdisziplinäres Crohn&Colitis Studienzentrum	Frankfurt	Hesse	Germany	60318
6	City Hospital Braunschweig	Braunschweig	Lower Saxony	Germany	38216
7	City Hospital Lueneburg	Lueneburg	Lower Saxony	Germany	21339
8	Gastroenterologisches Zentrum	Minden	Lower Saxony	Germany	32423
9	Internistische Facharztpraxis	Luedenscheid	Northrine-Westfalia	Germany	58507
10	Internistische Gemeinschaftspraxis	Ludwigshafen	Rhineland-Platinate	Germany	67067
11	University Clinics des Saarlandes	Homburg/Saar	Saarland	Germany	66421
12	UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,	Leipzig	Saxony	Germany	04103
13	Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen	Leipzig	Saxony	Germany	04105
14	Universitaetsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein	Germany	24105
15	Universitaetsklinikum Jena	Jena	Thuringa	Germany	07743
16	Gastroenterologische Praxis	Hamburg		Germany	20148
17	Kaunas Medical University Hospital , Department of Endoscopy	Kaunas		Lithuania	50009
18	Kaunas Medical University Hospital, Department of Gastroenterology	Kaunas		Lithuania	50009
19	Klaipeda Seamen Hospital	Klaipeda		Lithuania	92288
20	Siauliai District Hospital	Siauliai		Lithuania	76213
21	Santariskes Clinics Centras	Vilnius		Lithuania	01102
22	Clinical Hospital Colentina	Bucarest		Romania	020125
23	SC Endocenter Medicina Integrativa Bucuresti	Bucarest		Romania	021978
24	Cabinet Medical Individual Dr. Tirnaveanu	Oradea		Romania	410163
25	Algomed Policlinic Timisoara	Timisoara		Romania	300002
26	Policlinica Dr. Citu	Timisoara		Romania	300594