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

NCT01567956 | Terminated Phase 3 DMC

• 2 other identifiers: ST261DM110062011-004770-28
• Study Type: interventional
• Target: 150
• Locations: 8 countries
• Sites: 58

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  End of treatment (week 8)

Secondary Outcomes (9)

• Change from baseline in Rectal bleeding evaluation

  At week 2, 6 and 8 of treatment and after 4 week follow-up

• Change from baseline in stool frequency evaluation

  At week 2, 6 and 8 of treatment and after 4 week follow-up

• Histological response to the treatment

  End of treatment (week 8)

• Change from baseline in C-reactive protein (CRP) and Fibrinogen

  End of the treatment (week 8) and after 4 week follow-up

• Improvement of patients quality of life

  End of treatment period (week8) and after 4 week follow-up

Study Arms (2)

Propionyl-L-Carnitine

EXPERIMENTAL

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

Drug: Propionyl-L-Carnitine

Placebo

PLACEBO COMPARATOR

Modified release tablets containing inert substances

Drug: Placebo

Interventions

Propionyl-L-Carnitine DRUG

500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks

Propionyl-L-Carnitine

Placebo DRUG

500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead
• PRA Health Sciences: collaborator

Study Sites (58)

Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie

Innsbruck, 6020, Austria

Location

Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin

Salzburg, 5010, Austria

Location

Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III

Vienna, 1090, Austria

Location

Ordinationszentrum Döbling

Vienna, 1190, Austria

Location

Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun

Créteil, 94010, France

Location

Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie

Marseille, 13015, France

Location

Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie

Nantes, 44000, France

Location

Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif

Nice, 06202, France

Location

Hôpital Nord - Dept. of Gastroenterology

Picardie, 80 054, France

Location

Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie

Reims, 51092, France

Location

Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

Saint-Etienne, 42270, France

Location

Hôpital Rangueil Service de gastro-enterologie

Toulouse, 31079, France

Location

Hôpital Brabois Service de gastro-enterologie

Vandœuvre-lès-Nancy, 54511, France

Location

Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik

Berlin, 10117, Germany

Location

Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56

Bochum, 44791, Germany

Location

Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

Dresden, 01307, Germany

Location

Universtätsklinikum Schleswig-Holstein Gastroenterologie

Lübeck, 23538, Germany

Location

Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie

Magdeburg, 39120, Germany

Location

Universitätsmedizin Mannheim II. Medizinische Klinik

Mannheim, 68167, Germany

Location

Praxis Prof. Dr. med. Herbert Kellner

München, 80639, Germany

Location

Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin

Münster, 48149, Germany

Location

Gastroenterologische Fachpraxis am Germania Campus

Münster, 48159, Germany

Location

Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology

Stade, 21682, Germany

Location

Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház

Budapest, 1076, Hungary

Location

Semmelweis Egyetem 1st Internal Dept.

Budapest, 1083, Hungary

Location

Pannónia Magánorvosi Centrum Kft.

Budapest, 1136, Hungary

Location

Semmelweis Egyetem II. sz. Belgyógyászati Klinika

Budapest, H-1088, Hungary

Location

Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1

Gyula, 5700, Hungary

Location

Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály

Kaposvár, H-7400, Hungary

Location

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály

Miskolc, 3526, Hungary

Location

Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály

Mosonmagyaróvar, 9200, Hungary

Location

Clinfan Kft. SMO

Szekszárd, 7100, Hungary

Location

CRU Hungary Kft.

Szikszó, 3800, Hungary

Location

Daugavpils Central Regional Hospital

Daugavpils, LV-5400, Latvia

Location

Paula Stradina Clinical University Hospital Gastroenterology Centre

Riga, LV-1002, Latvia

Location

Latvian Maritime Medicine Centre

Riga, LV-1005, Latvia

Location

Digestive Disease Center GASTRO

Riga, LV-1006, Latvia

Location

Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius

Kaunas, LT-50009, Lithuania

Location

Klaipedos jurininku ligonine Diagnostikos skyrius

Klaipėda, LT-92288, Lithuania

Location

VšI Mykolo Marcinkeviciaus ligonines

Vilnius, LT-03215, Lithuania

Location

Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras

Vilnius, LT-08661, Lithuania

Location

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J

Ksawerów, 95-054, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej

Lódz, 90-153, Poland

Location

Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii

Olsztyn, 10-561, Poland

Location

Endoskopia Sp. z o.o.

Sopot, 81-756, Poland

Location

Nzoz Vivamed

Warsaw, 03-580, Poland

Location

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii

Wroclaw, 50-556, Poland

Location

Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii

Wroclaw, 51-149, Poland

Location

LexMedica

Wroclaw, 53-025, Poland

Location

ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew

Wroclaw, 53-333, Poland

Location

Fundación Hospital de Alcorcón Servicio de Gastroenterología

Alcorcón, 28922, Spain

Location

Centro Medico Teknon Servicio de Aparato Disgestivo

Barcelona, 08022, Spain

Location

Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo

El Palmar, 30120, Spain

Location

Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia

Madrid, 28006, Spain

Location

Hospital Universitario La Paz Servico de Gastroenterologia

Madrid, 28046, Spain

Location

Corporació Sanitaria Parc Taulí Servicio de Digestivo

Sabadell, 08028, Spain

Location

Hospital Universitario Marques de Valdecilla Servicio de Digestivo

Santander, 39008, Spain

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Sandro Ardizzone, MD

  Head of Inflammatory Bowel Diseases Unit Hospital "Luigi Sacco" Milan - ITALY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 30, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 7, 2016

Record last verified: 2014-04

Data Sharing

• IPD Sharing: Will not share

Locations

LA (4); LI (4); HU (10); DE (11); PL (9); FR (9); ES (7); AU (4)