Ulcerative ColitisPhase 2NCT01011322
A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
A Phase 2 study testing LT-02 in people with Ulcerative Colitis and Large Intestine, run by Lipid Therapeutics GmbH at 26 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Large Intestine, Diarrhea
- What is being tested?
- LT-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Dec 2009to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Germany16 sites
Gastroenterologische Praxis
Baden-Baden, Baden-Wurttemberg, 76530
City Hospital Braunschweig
Braunschweig, Lower Saxony, 38216
Interdisziplinäres Crohn&Colitis Studienzentrum
Frankfurt am Main, Hesse, 60318
Gastroenterologische Praxis
Hamburg, Free and Hanseatic City of Hamburg, 20148
University Clinic Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
University Clinics des Saarlandes
Homburg/Saar, Saarland, 66421
Universitaetsklinikum Jena
Jena, Thuringa, 07743
Universitaetsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
UK Leipzig AOR, Klinik für Gastroenterologie und Rheumatologie,
Leipzig, Saxony, 04103
Internistische Gemeinschaftspraxis fuer Verdauungserkrankungen
Leipzig, Saxony, 04105
Internistische Facharztpraxis
Lüdenscheid, Northrine-Westfalia, 58507
Internistische Gemeinschaftspraxis
Ludwigshafen, Rhineland-Platinate, 67067
City Hospital Lueneburg
Lüneburg, Lower Saxony, 21339
Gastroenterologisches Zentrum
Minden, Lower Saxony, 32423
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89070
Lithuania5 sites
Kaunas Medical University Hospital , Department of Endoscopy
Kaunas, Lithuania, 50009
Kaunas Medical University Hospital, Department of Gastroenterology
Kaunas, Lithuania, 50009
Klaipeda Seamen Hospital
Klaipėda, Lithuania, 92288
Siauliai District Hospital
Šiauliai, Lithuania, 76213
Santariskes Clinics Centras
Vilnius, Lithuania, 01102
Romania5 sites
Clinical Hospital Colentina
Bucharest, Romania, 020125
SC Endocenter Medicina Integrativa Bucuresti
Bucharest, Romania, 021978
Cabinet Medical Individual Dr. Tirnaveanu
Oradea, Romania, 410163
Algomed Policlinic Timisoara
Timișoara, Romania, 300002
Policlinica Dr. Citu
Timișoara, Romania, 300594
About this study
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
- Ulcerative Colitis, Large Intestine, Diarrhea, Abdominal Pain
- Being tested
- LT-02, placebo
- Medical subject headings
- Colitis, Ulcerative, Diarrhea, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-02Drug
Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| LT-02 Dose 1 | Experimental | 0.2g IMP per dose Receives: Drug: LT-02 |
| LT-02 Dose 2 | Experimental | 0.4g IMP per dose Receives: Drug: LT-02 |
| LT-02 Dose 3 | Experimental | 0.8g IMP per dose Receives: Drug: LT-02 |
| Sugar pill | Placebo comparator | placebo matching to 0g of IMP, Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
Measured: From day 1 of treatment until end of treatment
Secondary outcomes (1)
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
Measured: After study is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipid Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Max Karner, MD, Principal investigator, University Clinic Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011322
- Sponsor's protocol ID
- LT-02-UC-01
- Other IDs
- 2008-007952-90, 2008
- Status last verified
- Aug 2010
- First submitted
- 10 Nov 2009
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24796768
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01011322
- Acronym / sponsor ID
- LT-02-UC-01
- Conditions
- Ulcerative Colitis, Large Intestine, Diarrhea, Abdominal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Lipid Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (estimated)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LT-02 Dose 1 | Experimental | Drug: LT-020.2g IMP per dose |
| LT-02 Dose 2 | Experimental | Drug: LT-020.4g IMP per dose |
| LT-02 Dose 3 | Experimental | Drug: LT-020.8g IMP per dose |
| Sugar pill | Placebo comparator | Drug: placeboplacebo matching to 0g of IMP, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT-02Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks | Drug | LT-02 Dose 1, LT-02 Dose 2, LT-02 Dose 3 |
| placeboplacebo | Drug | Sugar pill |
Primary outcome
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis
Time frame: From day 1 of treatment until end of treatment
1 secondary outcome
To determine the optimal dose of IMP in mesalazine-refractory ulcerative colitis
Time frame: After study is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
- Derived from this study: PubMed 24796768Karner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Karner, MD principal investigator
University Clinic Heidelberg, Germany
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LT-02 in people with Ulcerative Colitis and Large Intestine, run by Lipid Therapeutics GmbH at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Lithuania, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis (time frame: From day 1 of treatment until end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.