Propionyl-L-Carnitine in Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:
NCT01026857
First received: December 4, 2009
Last updated: December 16, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to determine whether Propionyl-L-carnitine administration may ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in treatment with one of the standard treatments (corticosteroids excluded).


Condition Intervention Phase
Ulcerative Colitis
Drug: Propionyl-L-Carnitine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomised, Multicenter Study to Investigate the Efficacy of Two Dosages of Propionyl-L-Carnitine Colon Release Tablets in Patients Affected by Ulcerative Colitis Under Oral Stable Treatment

Resource links provided by NLM:


Further study details as provided by sigma-tau i.f.r. S.p.A.:

Primary Outcome Measures:
  • Disease Activity Index score [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 121
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLC Colon release tablet 1 g
40 patients each arm
Drug: Propionyl-L-Carnitine
PLC colon release tablet 1 g/die for 4 weeks
Other Name: Dromos
Drug: Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks
Other Name: Placebo
Experimental: PLC colon release tablet 2 g
40 patients each arm
Drug: Propionyl-L-Carnitine
PLC colon release tablet 2 g/die for 4 weeks
Other Name: Dromos
Drug: Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks
Other Name: Placebo
Placebo Comparator: Placebo PLC colon release tablet 2 g
40 patients each arm
Drug: Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks
Other Name: Placebo

Detailed Description:

The trial foresees the administration of 2 different dosages of Propionyl-L-carnitine (ST261) colon release tablets, 1 g/die and 2 g/die. The primary objective of this trial is to evaluate the clinical/endoscopic response defined as a lowering of the Disease Activity Index (DAI score) of at least 3 points ot the reaching of remission, the clinical/endoscopic remission (DAI score <= 2 with no individual subscore > 1) and histological efficacy of the two combined dosages of PLC (i.e. PLC 1 g/die + 2 g/die) in comparison to placebo, defined as an improvement of the Histological Index (HI) of at least 1 point at the end of the study (a final HI score of <= 1 will be defined as an histological remission).

The secondary objective is to evaluate the clinical/endoscopic and histological efficacy of the two dosages of PLC individually considered in comparison to Placebo, in order to gather information on the dosage to be used in subsequent trials. The safety and tolerability of the regimens studied will also be objectives of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have read the Information for the Patient and signed the Informed Consent Form.
  • Age comprised between 18 and 75 included.
  • If female, not pregnant or nursing.
  • For women of childbearing potential, willingness to avoid a pregnancy during the treatment period and for at least 1 month from the last dose of drug.
  • Availability of a pancolonoscopy and histology both confirming the diagnosis of active ulcerative colitis.
  • Disease Activity Index comprised between 3 and 10, inclusive, (mild to moderate ulcerative colitis).
  • On one of the following treatments for ulcerative colitis prior to baseline visit:

    1. Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or sulfasalazine therapy for greater than or equal to 4 weeks prior to baseline assessments.
    2. Stable background mercaptopurine or azathioprine for greater than or equal to 12 weeks prior to baseline assessments.

Exclusion Criteria:

  • First diagnosis of ulcerative colitis.
  • Crohn's disease.
  • Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
  • Use of antibiotics in the last 10 days preceding the screening.
  • Use of NSAID's in the last 10 days preceding the screening.
  • Use of probiotics in the last 10 days preceding the screening
  • Positive stool culture (when performed, according to Investigator's judgment, to assess possible parasitologic infection(s)).
  • Significantly impaired liver, renal, pulmonary or cardiovascular function.
  • History of colon resection.
  • Diverticulitis.
  • Diagnosis of proctitis
  • Stable rectally administered therapy in the last 10 days.
  • Active or chronic infection(s).
  • Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study.
  • Any physical or psychological condition in a patient that could let the investigator suspect his/her poor compliance.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026857

Locations
Italy
Hospital Morgagni - Pierantoni
Forlì, Italy, 47100
Ospedale "L. Sacco"
Milan, Italy, 20157
University Federico II
Naples, Italy, 80131
Policlinico "A. Gemelli"
Rome, Italy, 00168
Hospital S. Filippo Neri
Rome, Italy, 00135
Lithuania
Kaunas Medical University Clinic
Kaunas, Lithuania, 50009
Vilnius University Santariskiu Hospital
Vilnius, Lithuania, 08661
Poland
Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1
Lodz, Poland, 90-153
Samodzielny Publiczny Szpital Kliniczny Nr 3 Katedra i Klinika Gastroenterologii AM
Wroclaw, Poland, 50-326
Wojewódzki Szpital Specjalistyczny Klinika Gastroenterologii
Wroclaw, Poland, 51-149
Russian Federation
Federal State Institution "7-th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia"
Moscow, Russian Federation, 107014
Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij"
Moscow, Russian Federation, 123154
State Institution "Regional Military Clinical Hospital № 442 named after Z.P. Solovyov of Ministry of Defence of Russia"
Saint Petersburg, Russian Federation, 193163
Federal State Healthcare Institution "Clinical Hospital № 122 named after L.G. Sokolov of Federal Medical and Biological Agency"
Saint Petersburg, Russian Federation, 194291
St-Petersburg State Healthcare Institution "Municipal Hospital № 26"
Saint Petersburg, Russian Federation, 196247
Sponsors and Collaborators
sigma-tau i.f.r. S.p.A.
Investigators
Principal Investigator: Giovanni B. Gasbarrini, M.D. Policlinico Universitario "A. Gemelli" - Rome - Italy
Principal Investigator: Gabriele Bianchi Porro, M.D. Ospedale "L. Sacco" - Milan - Italy
Principal Investigator: Agesilao D'Arienzo, M.D. A.O. Universitaria Federico II - Naples - Italy
Principal Investigator: Daniela Valpiani, M.D. P.O. Morgagni Pierantoni - Forlì - Italy
Principal Investigator: Maurizio Koch, M.D. Ospedale "S. Filippo Neri" - Rome - Italy
Principal Investigator: Ewa Malecka-Panas, M.D. Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1 - Lodz - Poland
Principal Investigator: Leszek Paradowski, M.D. Samodzielny Publiczny Szpital Kliniczny Nr 3 - Wroclaw - Poland
Principal Investigator: Konrad Lesniakowski, M.D. Wojewodzki Szpital - Wroclaw - Poland
Principal Investigator: Limas Kupcinskas, M.D. Kaunas Medical University Clinic - Kaunas - Lithuania
Principal Investigator: Goda Denapiene, M.D. Vilnius University Santariskiu Hospital - Vilnius - Lithuania
Principal Investigator: Vladimir B. Grinevich, M.D. State Institution "Regional Military Clinical Hospital N°422 named after Solovyov of Ministry of Defence of Russia - Saint Petersburg - Russia
Principal Investigator: Elena Sishkova, M.D. Federal State Healthcare Institution "Clinical Hospital N°122 named after L.G. Sokolov of Federal Medical and Biological Agency" - Saint Petersburg - Russia
Principal Investigator: Konstantin P. Zhidkov, M.D. St Petersburg State Healthcare Institution "Municipal Hospital N°26" - Saint Petersburg - Russia
Principal Investigator: Igor G. Bakulin, M.D. Federal State Institution "7th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia" - Moscow - Russia
Principal Investigator: Tatiana L. Mikhailova, M.D. Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij" - Moscow - Russia
  More Information

No publications provided by sigma-tau i.f.r. S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Giovanni Battista Gasbarrini Coordinator, Policlinico "A. Gemelli" - Rome
ClinicalTrials.gov Identifier: NCT01026857     History of Changes
Other Study ID Numbers: ST261 DM 01 004
Study First Received: December 4, 2009
Last Updated: December 16, 2009
Health Authority: Italy: Ethics Committee
Lithuania: Bioethics Committee
Poland: Ethics Committee
Russia: Ethics Committee

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014