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

NCT01538251 | Terminated Phase 3 DMC

• 2 other identifiers: ST261DM110052011-004765-32
• Study Type: interventional
• Target: 147
• 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; propionyl-l-carnitine

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 500 mg

Drug: Propionyl-L-Carnitine

Placebo

PLACEBO COMPARATOR

Modified release tablet 500 mg

Drug: Placebo

Interventions

Propionyl-L-Carnitine DRUG

Modified release tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.

Propionyl-L-carnitine

Placebo DRUG

Tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.

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

Study Sites (58)

Imelda Ziekenhuis

Bonheiden, Antwerpen, 2820, Belgium

Location

Universitaire Ziekenhuis Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Oost-vlaanderen, 9000, Belgium

Location

H. Hartziekenhuis Roeselare-Menen vzw

Roeselare, West-vlaanderen, 8800, Belgium

Location

Derma Plus s.r.o.

České Budějovice, 370 01, Czechia

Location

Hepato-Gastroenterology HK s.r.o.

Hradec Králové, 500 12, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

G.E.P. Clinic s.r.o.

Prague, 100 00, Czechia

Location

MONSE s.r.o

Prague, 118 33, Czechia

Location

Fakultní Nemocnice v Motole

Prague, 15006, Czechia

Location

Fakultní Thomayerova nemocnice s poliklinikou

Praha 4 - Krc, 140 59, Czechia

Location

Nemocnice Tábor, a.s.

Tábor, 390 03, Czechia

Location

Orlickoústecká Nemocnice a.s

Ústí nad Orlicí, 562 18, Czechia

Location

Soroka University Medical Center

Beersheba, 84100, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah Medical Organization, Ein Kerem

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel Aviv Souraski Medical Center

Tel Aviv, 64239, Israel

Location

Assaf Harofeh Medical Centre

Ẕerifin, 70300, Israel

Location

Ospedale "G.B.Morgagni - L. Pierantoni"

Forlì, Forli-cesena, 47100, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Ospedale Luigi Sacco - Az. Osp. Dept. of Gastroenterology

Milan, 20157, Italy

Location

Policlinico Universitario Federico II

Napoli, 80131, Italy

Location

IRCSS Policlinico San Matteo

Pavia, 27100, Italy

Location

Azienda Ospedaliera S. Camillo Forlanini, Roma

Roma, 00152, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1091 AC, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

CMI de Gastroenterologie Dobru Daniela

Târgu Mureş, Mureș County, 540461, Romania

Location

Neomed Research

Brasov, 500283, Romania

Location

Centrul Medical Sana

Bucharest, 011025, Romania

Location

Endocenter Medicina Integrativa SRL

Bucharest, 021978, Romania

Location

Gastromedica SRL

Iași, 700506, Romania

Location

Spitalul Clinic Judetean De Urgenta Sibiu

Sibiu, 550245, Romania

Location

Policlinic Algomed SRL

Timișoara, 300002, Romania

Location

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

State Educational Institution of Higher Professional Education Novosibirsk State Medical University

Novosibirsk, 630091, Russia

Location

State Research Institute of Physiology of Siberian Branch of Russian Academy of Medical Sciences

Novosibirsk, 630117, Russia

Location

GOU VPO Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Saint Petersburg GUZ City Policlinic 38

Saint Petersburg, 193015, Russia

Location

Regional Military Clinical Hospital ¿ 442 named after Z.P. Solovyov of Ministry of Defence of Russia

Saint Petersburg, 193124, Russia

Location

Saint-Petersburg Medical Academy

Saint Petersburg, 195067, Russia

Location

Saint-Petersburg State Institution of Health Protection City Hospital # 26

Saint Petersburg, 196247, Russia

Location

Krestovsky Medical Institute

Saint Petersburg, 197110, Russia

Location

Saratov City Hospital #2

Saratov, 410053, Russia

Location

State Educational Institution of Higher Professional Education "Stavropol State Medical Academy"

Stavropol, 355017, Russia

Location

Clinical Hospital #2

Yaroslavl, 150010, Russia

Location

NovaMed spol. s.r.o.

Banská Bystrica, 974 01, Slovakia

Location

UNB Nemocnica Staré Mesto

Bratislava, 813 69, Slovakia

Location

ABAWI spol.s.r.o.

Bratislava, 82101, Slovakia

Location

Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion

Bratislava, 831 04, Slovakia

Location

Neštátna Gastroenterologická Ambulancia

Bratislava, 851 01, Slovakia

Location

KM Management sro

Nitra, 950 01, Slovakia

Location

Gastro I.s.r.o.

Prešov, 08001, Slovakia

Location

GEA s.r.o Gastroenterologicka ambulancia

Trnava, 91701, Slovakia

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 DIRECTOR

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: February 20, 2012
• First Posted: February 24, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 7, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7); RO (7); SL (8); CZ (9); BE (4); NL (3); IL (8); RU (12)