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Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Propionyl-L-Carnitine
Placebo
Sponsored by
sigma-tau i.f.r. S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have read the Information for the Patient and signed the Informed Consent Form.
  • Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed endoscopically and histologically.
  • Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis), with rectal bleeding sub-score of at least 1.
  • Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments.
  • If female, not pregnant or nursing. For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug and utilization of an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication.

Exclusion Criteria:

  • Crohn's disease and indeterminate colitis.
  • Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
  • Use of systemic antibiotics in the last 10 days preceding the screening.
  • Use of systemic Nonsteroidal anti-inflammatory drugs on a repeat basis in the last 10 days preceding the screening.
  • Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study.
  • Use of immunosuppressants or biological agents within the last 6 weeks preceding the screening.
  • Treatment with L-carnitine or its esters derivatives within the last 3 months.
  • Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile).
  • Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator.
  • History of colon resection.
  • Diverticulitis, symptomatic diverticulosis.
  • Active peptic ulcer disease.
  • Proctitis (extent of inflammation < 15 cm from the anus).
  • Bleeding disorders
  • Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening.
  • Active or chronic infection(s) or malignancies.
  • Known hypersensitivity to the active ingredient and excipients of the study drug
  • Patients treated with L-Carnitine or its esters derivatives during the 3 months preceding the screening phase.

Sites / Locations

  • Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie
  • Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin
  • Ordinationszentrum Döbling
  • Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III
  • Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun
  • Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie
  • Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie
  • Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif
  • Hôpital Nord - Dept. of Gastroenterology
  • Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie
  • Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
  • Hôpital Rangueil Service de gastro-enterologie
  • Hôpital Brabois Service de gastro-enterologie
  • Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik
  • Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56
  • Klinikum Braunschweig
  • Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
  • Universtätsklinikum Schleswig-Holstein Gastroenterologie
  • Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie
  • Universitätsmedizin Mannheim II. Medizinische Klinik
  • Praxis Prof. Dr. med. Herbert Kellner
  • Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin
  • Gastroenterologische Fachpraxis am Germania Campus
  • Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology
  • Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház
  • Semmelweis Egyetem 1st Internal Dept.
  • Pannónia Magánorvosi Centrum Kft.
  • Semmelweis Egyetem II. sz. Belgyógyászati Klinika
  • Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1
  • Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály
  • Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály
  • Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály
  • Clinfan Kft. SMO
  • CRU Hungary Kft.
  • Daugavpils Central Regional Hospital
  • Paula Stradina Clinical University Hospital Gastroenterology Centre
  • Latvian Maritime Medicine Centre
  • Digestive Disease Center GASTRO
  • Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius
  • Klaipedos jurininku ligonine Diagnostikos skyrius
  • VšI Mykolo Marcinkeviciaus ligonines
  • Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras
  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J
  • SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej
  • Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii
  • Endoskopia Sp. z o.o.
  • Nzoz Vivamed
  • Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii
  • Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii
  • LexMedica
  • ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew
  • Fundación Hospital de Alcorcón Servicio de Gastroenterología
  • Centro Medico Teknon Servicio de Aparato Disgestivo
  • Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo
  • Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia
  • Hospital Universitario La Paz Servico de Gastroenterologia
  • Corporació Sanitaria Parc Taulí Servicio de Digestivo
  • Hospital Universitario Marques de Valdecilla Servicio de Digestivo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propionyl-L-Carnitine

Placebo

Arm Description

Modified release tablets containing 500 mg of propionyl-L-carnitine

Modified release tablets containing inert substances

Outcomes

Primary Outcome Measures

Proportion of clinical/endoscopic remissions
Remission will be defined according with the overall modified Mayo score (Disease Activity Index). A score ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1 will be considered necessary to classify the patient in remission state.

Secondary Outcome Measures

Change from baseline in Rectal bleeding evaluation
Evaluation will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
Change from baseline in stool frequency evaluation
Evaluations will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
Histological response to the treatment
Evaluated as an improvement of the histological index of at least 1 point
Change from baseline in C-reactive protein (CRP) and Fibrinogen
Improvement of patients quality of life
A validated specific questionnaire, the SIBDQ by McMaster university will be administered to evaluate changes in patients' quality of life
Haematology
Haemoglobin, Haematocrit, RBC, WBC and differential count.
Electrocardiogram
Standard intervals (PR, RR, QRS, QT) will be collected plus all rhythm abnormalities
Adverse Events collection
Serum Chemistry
Standard evaluation including renal and liver function, electrolytes and blood glucose

Full Information

First Posted
March 28, 2012
Last Updated
November 4, 2016
Sponsor
sigma-tau i.f.r. S.p.A.
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01567956
Brief Title
Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study
Official Title
Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Evidence of very low probability to success. No safety issues
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
sigma-tau i.f.r. S.p.A.
Collaborators
PRA Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be investigated.
Detailed Description
Although it seems clear that an abnormal function of the colonic epithelium is the central problem causing inflammation and the unusual immunological response to the normal gut flora in inflammatory bowel disease (IBD), the actual causes of these dysfunctions are still unknown. Short Chain Fatty Acids (SCFA) are the main fuel of the colonic epithelium, and are normally produced by the bacterial flora by fermentation of the complex carbohydrates forming non soluble fibers usually introduced with everyday diet. Butyrate alone contributes 70% of the normal colonocyte energy. Studies done using animal models and colonic mucosa biopsies from patients suffering form ulcerative colitis (UC) have consistently shown that a metabolic change occurs in diseased colonic mucosa, with an impairment of butyrate oxidation (and of beta-oxidation) and an energy shortage that is only incompletely compensated by oxidation of glucose and other substrates such as glutamine. It is also well known that matrix metalloproteases production is highly increased in IBD and that serum transglutaminase activity is significantly reduced in patients with IBD. Transglutaminases are enzymes contributing to the crosslinking of matrix proteins and the reduction seen in patients affected by IBD correlates well with the endoscopic and histopathologic grading in UC, meaning that part of the circulating enzyme is sequestered in the injured colonic tissue in the effort to re-build the extracellular matrix during the healing process. Propionyl-L-carnitine Hydrochloride (PLC) is a molecule that has already been shown to reduce membrane lipid peroxidation in endothelial cells from bovine aorta and coronary vessels, to reduce the effects of hypoxia in coronary endothelial cells, and to play a role in the cardiac metabolic abnormalities that contribute to the mechanical dysfunctions leading to heart failure. Given these properties of Propionyl-L-carnitine Hydrochloride (ST 261) and given the peroxidative damage suffered by colonocytes in UC together with their metabolic impairment, the use of this molecule for the treatment of UC seemed to be appropriate and sound, in particular as a carrier of a propionate moiety that, once transformed into succinate, enters the Kreb cycle, acting as an extra burst fuel improving the balance of energy production inside tissues. Previous clinical experience has shown that PLC promoted complete or nearly complete regression of cutaneous trophic ulcers in a large number of vasculopathic patients refractory to all other therapies. As far as the UC pathology is concerned, the effects of ST 261, given orally or intrarectally, were investigated at different dosages, in preclinical experimentation, either after a single trinitrobenzene sulphonic acid (TNBS) administration (acute colitis) or after repeated TNBS administrations (reactivated colitis). The results showed a reduction in the damaged colon area both in acute model and reactivated colitis, even if the beneficial effect of restoration of TNBS-induced alterations of tissue morphology is more evident in the reactivated colitis model, particularly after oral administration. Based on the above-described results a development plan in humans started to investigate the activity of PLC in the treatment of ulcerative colitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propionyl-L-Carnitine
Arm Type
Experimental
Arm Description
Modified release tablets containing 500 mg of propionyl-L-carnitine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Modified release tablets containing inert substances
Intervention Type
Drug
Intervention Name(s)
Propionyl-L-Carnitine
Intervention Description
500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks
Primary Outcome Measure Information:
Title
Proportion of clinical/endoscopic remissions
Description
Remission will be defined according with the overall modified Mayo score (Disease Activity Index). A score ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1 will be considered necessary to classify the patient in remission state.
Time Frame
End of treatment (week 8)
Secondary Outcome Measure Information:
Title
Change from baseline in Rectal bleeding evaluation
Description
Evaluation will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
Time Frame
At week 2, 6 and 8 of treatment and after 4 week follow-up
Title
Change from baseline in stool frequency evaluation
Description
Evaluations will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).
Time Frame
At week 2, 6 and 8 of treatment and after 4 week follow-up
Title
Histological response to the treatment
Description
Evaluated as an improvement of the histological index of at least 1 point
Time Frame
End of treatment (week 8)
Title
Change from baseline in C-reactive protein (CRP) and Fibrinogen
Time Frame
End of the treatment (week 8) and after 4 week follow-up
Title
Improvement of patients quality of life
Description
A validated specific questionnaire, the SIBDQ by McMaster university will be administered to evaluate changes in patients' quality of life
Time Frame
End of treatment period (week8) and after 4 week follow-up
Title
Haematology
Description
Haemoglobin, Haematocrit, RBC, WBC and differential count.
Time Frame
Baseline and end of treatment (week8)
Title
Electrocardiogram
Description
Standard intervals (PR, RR, QRS, QT) will be collected plus all rhythm abnormalities
Time Frame
At baseline and at the end of treatment period (week8)
Title
Adverse Events collection
Time Frame
12 weeks
Title
Serum Chemistry
Description
Standard evaluation including renal and liver function, electrolytes and blood glucose
Time Frame
At baseline and at the end of treatment period (week8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have read the Information for the Patient and signed the Informed Consent Form. Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed endoscopically and histologically. Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis), with rectal bleeding sub-score of at least 1. Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments. If female, not pregnant or nursing. For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug and utilization of an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication. Exclusion Criteria: Crohn's disease and indeterminate colitis. Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids. Use of systemic antibiotics in the last 10 days preceding the screening. Use of systemic Nonsteroidal anti-inflammatory drugs on a repeat basis in the last 10 days preceding the screening. Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study. Use of immunosuppressants or biological agents within the last 6 weeks preceding the screening. Treatment with L-carnitine or its esters derivatives within the last 3 months. Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile). Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator. History of colon resection. Diverticulitis, symptomatic diverticulosis. Active peptic ulcer disease. Proctitis (extent of inflammation < 15 cm from the anus). Bleeding disorders Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening. Active or chronic infection(s) or malignancies. Known hypersensitivity to the active ingredient and excipients of the study drug Patients treated with L-Carnitine or its esters derivatives during the 3 months preceding the screening phase.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Ardizzone, MD
Organizational Affiliation
Head of Inflammatory Bowel Diseases Unit Hospital "Luigi Sacco" Milan - ITALY
Official's Role
Study Chair
Facility Information:
Facility Name
Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin
City
Salzburg
ZIP/Postal Code
5010
Country
Austria
Facility Name
Ordinationszentrum Döbling
City
Vienna
ZIP/Postal Code
1190
Country
Austria
Facility Name
Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Nord - Dept. of Gastroenterology
City
Picardie
ZIP/Postal Code
80 054
Country
France
Facility Name
Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie
City
Reims cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie
City
Saint-Etienne
ZIP/Postal Code
42270
Country
France
Facility Name
Hôpital Rangueil Service de gastro-enterologie
City
Toulouse Cedex 4
ZIP/Postal Code
31079
Country
France
Facility Name
Hôpital Brabois Service de gastro-enterologie
City
Vandoeuvre Les Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universtätsklinikum Schleswig-Holstein Gastroenterologie
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitätsmedizin Mannheim II. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Praxis Prof. Dr. med. Herbert Kellner
City
München
ZIP/Postal Code
80639
Country
Germany
Facility Name
Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Gastroenterologische Fachpraxis am Germania Campus
City
Münster
ZIP/Postal Code
48159
Country
Germany
Facility Name
Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology
City
Stade
ZIP/Postal Code
21682
Country
Germany
Facility Name
Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Semmelweis Egyetem 1st Internal Dept.
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Pannónia Magánorvosi Centrum Kft.
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Semmelweis Egyetem II. sz. Belgyógyászati Klinika
City
Budapest
ZIP/Postal Code
H-1088
Country
Hungary
Facility Name
Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály
City
Kaposvár
ZIP/Postal Code
H-7400
Country
Hungary
Facility Name
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály
City
Mosonmagyaróvar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Clinfan Kft. SMO
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Szikszó
ZIP/Postal Code
3800
Country
Hungary
Facility Name
Daugavpils Central Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5400
Country
Latvia
Facility Name
Paula Stradina Clinical University Hospital Gastroenterology Centre
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Latvian Maritime Medicine Centre
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Digestive Disease Center GASTRO
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Klaipedos jurininku ligonine Diagnostikos skyrius
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
VšI Mykolo Marcinkeviciaus ligonines
City
Vilnius
ZIP/Postal Code
LT-03215
Country
Lithuania
Facility Name
Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J
City
Ksawerów
ZIP/Postal Code
95-054
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej
City
Lódz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Nzoz Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii
City
Wroclaw
ZIP/Postal Code
51-149
Country
Poland
Facility Name
LexMedica
City
Wroclaw
ZIP/Postal Code
53-025
Country
Poland
Facility Name
ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew
City
Wroclaw
ZIP/Postal Code
53-333
Country
Poland
Facility Name
Fundación Hospital de Alcorcón Servicio de Gastroenterología
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Facility Name
Centro Medico Teknon Servicio de Aparato Disgestivo
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz Servico de Gastroenterologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Corporació Sanitaria Parc Taulí Servicio de Digestivo
City
Sabadell
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla Servicio de Digestivo
City
Santander
ZIP/Postal Code
39008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

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