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

Primary Purpose

Ulcerative Colitis, Large Intestine, Diarrhea

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LT-02
placebo
Sponsored by
Lipid Therapeutics GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gastroenterologische Praxis
  • University Clinic Heidelberg
  • Robert-Bosch-Krankenhaus
  • Universitaetsklinikum Ulm
  • Interdisziplinäres Crohn&Colitis Studienzentrum
  • City Hospital Braunschweig
  • City Hospital Lueneburg
  • Gastroenterologisches Zentrum
  • Internistische Facharztpraxis
  • Internistische Gemeinschaftspraxis
  • University Clinics des Saarlandes
  • UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
  • Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
  • Universitaetsklinikum Schleswig-Holstein
  • Universitaetsklinikum Jena
  • Gastroenterologische Praxis
  • Kaunas Medical University Hospital , Department of Endoscopy
  • Kaunas Medical University Hospital, Department of Gastroenterology
  • Klaipeda Seamen Hospital
  • Siauliai District Hospital
  • Santariskes Clinics Centras
  • Clinical Hospital Colentina
  • SC Endocenter Medicina Integrativa Bucuresti
  • Cabinet Medical Individual Dr. Tirnaveanu
  • Algomed Policlinic Timisoara
  • Policlinica Dr. Citu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LT-02 Dose 1

LT-02 Dose 2

LT-02 Dose 3

Sugar pill

Arm Description

0.2g IMP per dose

0.4g IMP per dose

0.8g IMP per dose

placebo matching to 0g of IMP,

Outcomes

Primary Outcome Measures

To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis

Secondary Outcome Measures

To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis

Full Information

First Posted
November 10, 2009
Last Updated
November 15, 2011
Sponsor
Lipid Therapeutics GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01011322
Brief Title
A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lipid Therapeutics GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Large Intestine, Diarrhea, Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LT-02 Dose 1
Arm Type
Experimental
Arm Description
0.2g IMP per dose
Arm Title
LT-02 Dose 2
Arm Type
Experimental
Arm Description
0.4g IMP per dose
Arm Title
LT-02 Dose 3
Arm Type
Experimental
Arm Description
0.8g IMP per dose
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
placebo matching to 0g of IMP,
Intervention Type
Drug
Intervention Name(s)
LT-02
Intervention Description
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
Time Frame
From day 1 of treatment until end of treatment
Secondary Outcome Measure Information:
Title
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
Time Frame
After study is completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Karner, MD
Organizational Affiliation
University Clinic Heidelberg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterologische Praxis
City
Baden-Baden
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76530
Country
Germany
Facility Name
University Clinic Heidelberg
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
State/Province
Baden-Wuerttemberg
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89070
Country
Germany
Facility Name
Interdisziplinäres Crohn&Colitis Studienzentrum
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60318
Country
Germany
Facility Name
City Hospital Braunschweig
City
Braunschweig
State/Province
Lower Saxony
ZIP/Postal Code
38216
Country
Germany
Facility Name
City Hospital Lueneburg
City
Lueneburg
State/Province
Lower Saxony
ZIP/Postal Code
21339
Country
Germany
Facility Name
Gastroenterologisches Zentrum
City
Minden
State/Province
Lower Saxony
ZIP/Postal Code
32423
Country
Germany
Facility Name
Internistische Facharztpraxis
City
Luedenscheid
State/Province
Northrine-Westfalia
ZIP/Postal Code
58507
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis
City
Ludwigshafen
State/Province
Rhineland-Platinate
ZIP/Postal Code
67067
Country
Germany
Facility Name
University Clinics des Saarlandes
City
Homburg/Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04105
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
State/Province
Thuringa
ZIP/Postal Code
07743
Country
Germany
Facility Name
Gastroenterologische Praxis
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
Facility Name
Kaunas Medical University Hospital , Department of Endoscopy
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Kaunas Medical University Hospital, Department of Gastroenterology
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda Seamen Hospital
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Siauliai District Hospital
City
Siauliai
ZIP/Postal Code
76213
Country
Lithuania
Facility Name
Santariskes Clinics Centras
City
Vilnius
ZIP/Postal Code
01102
Country
Lithuania
Facility Name
Clinical Hospital Colentina
City
Bucarest
ZIP/Postal Code
020125
Country
Romania
Facility Name
SC Endocenter Medicina Integrativa Bucuresti
City
Bucarest
ZIP/Postal Code
021978
Country
Romania
Facility Name
Cabinet Medical Individual Dr. Tirnaveanu
City
Oradea
ZIP/Postal Code
410163
Country
Romania
Facility Name
Algomed Policlinic Timisoara
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Policlinica Dr. Citu
City
Timisoara
ZIP/Postal Code
300594
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
24796768
Citation
Karner M, Kocjan A, Stein J, Schreiber S, von Boyen G, Uebel P, Schmidt C, Kupcinskas L, Dina I, Zuelch F, Keilhauer G, Stremmel W. First multicenter study of modified release phosphatidylcholine "LT-02" in ulcerative colitis: a randomized, placebo-controlled trial in mesalazine-refractory courses. Am J Gastroenterol. 2014 Jul;109(7):1041-51. doi: 10.1038/ajg.2014.104. Epub 2014 May 6.
Results Reference
derived

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

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