Propionyl-L-Carnitine in Ulcerative Colitis

June 13, 2017 updated by: sigma-tau i.f.r. S.p.A.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Forlì, Italy, 47100
        • Hospital Morgagni - Pierantoni
      • Milan, Italy, 20157
        • Ospedale "L. Sacco"
      • Naples, Italy, 80131
        • University Federico II
      • Rome, Italy, 00135
        • Hospital S. Filippo Neri
      • Rome, Italy, 00168
        • Policlinico "A. Gemelli"
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Kaunas Medical University Clinic
      • Vilnius, Lithuania, 08661
        • Vilnius University Santariskiu Hospital
  • Poland
      • Lodz, Poland, 90-153
        • Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1
      • Wroclaw, Poland, 50-326
        • Samodzielny Publiczny Szpital Kliniczny Nr 3 Katedra i Klinika Gastroenterologii AM
      • Wroclaw, Poland, 51-149
        • Wojewódzki Szpital Specjalistyczny Klinika Gastroenterologii
  • Russian Federation
      • Moscow, Russian Federation, 107014
        • Federal State Institution "7-th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia"
      • Moscow, Russian Federation, 123154
        • Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij"
      • Saint Petersburg, Russian Federation, 193163
        • State Institution "Regional Military Clinical Hospital № 442 named after Z.P. Solovyov of Ministry of Defence of Russia"
      • Saint Petersburg, Russian Federation, 194291
        • Federal State Healthcare Institution "Clinical Hospital № 122 named after L.G. Sokolov of Federal Medical and Biological Agency"
      • Saint Petersburg, Russian Federation, 196247
        • St-Petersburg State Healthcare Institution "Municipal Hospital № 26"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Dromos
Drug: Propionyl-L-Carnitine
PLC colon release tablet 2 g/die for 4 weeks
Other Names:
  • Dromos
Drug: Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks
Experimental: PLC colon release tablet 2 g
40 patients each arm
Drug: Propionyl-L-Carnitine
PLC colon release tablet 1 g/die for 4 weeks
Other Names:
  • Dromos
Drug: Propionyl-L-Carnitine
PLC colon release tablet 2 g/die for 4 weeks
Other Names:
  • Dromos
Drug: Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Activity Index score
Time Frame: baseline, week 4
baseline, week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimate)

December 7, 2009

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST261 DM 01 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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