NCT01026857

Brief Summary

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
Last Updated

June 15, 2017

Status Verified

December 1, 2009

Enrollment Period

2.9 years

First QC Date

December 4, 2009

Last Update Submit

June 13, 2017

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Disease Activity Index score

    baseline, week 4

Secondary Outcomes (1)

  • Adverse Events

    Throughout the study

Study Arms (3)

PLC Colon release tablet 1 g

EXPERIMENTAL

40 patients each arm

Drug: Propionyl-L-CarnitineDrug: Placebo

PLC colon release tablet 2 g

EXPERIMENTAL

40 patients each arm

Drug: Propionyl-L-CarnitineDrug: Placebo

Placebo PLC colon release tablet 2 g

PLACEBO COMPARATOR

40 patients each arm

Drug: Placebo

Interventions

Propionyl-L-CarnitineDRUG

PLC colon release tablet 1 g/die for 4 weeks

Also known as: Dromos
PLC Colon release tablet 1 g
PlaceboDRUG

Placebo PLC colon release tablet 2 g/die for 4 weeks

PLC Colon release tablet 1 gPLC colon release tablet 2 gPlacebo PLC colon release tablet 2 g

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital Morgagni - Pierantoni

Forlì, 47100, Italy

Location

Ospedale "L. Sacco"

Milan, 20157, Italy

Location

University Federico II

Naples, 80131, Italy

Location

Hospital S. Filippo Neri

Rome, 00135, Italy

Location

Policlinico "A. Gemelli"

Rome, 00168, Italy

Location

Kaunas Medical University Clinic

Kaunas, 50009, Lithuania

Location

Vilnius University Santariskiu Hospital

Vilnius, 08661, Lithuania

Location

Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1

Lodz, 90-153, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 3 Katedra i Klinika Gastroenterologii AM

Wroclaw, 50-326, Poland

Location

Wojewódzki Szpital Specjalistyczny Klinika Gastroenterologii

Wroclaw, 51-149, Poland

Location

Federal State Institution "7-th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia"

Moscow, 107014, Russia

Location

Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij"

Moscow, 123154, Russia

Location

State Institution "Regional Military Clinical Hospital № 442 named after Z.P. Solovyov of Ministry of Defence of Russia"

Saint Petersburg, 193163, Russia

Location

Federal State Healthcare Institution "Clinical Hospital № 122 named after L.G. Sokolov of Federal Medical and Biological Agency"

Saint Petersburg, 194291, Russia

Location

St-Petersburg State Healthcare Institution "Municipal Hospital № 26"

Saint Petersburg, 196247, Russia

Location

Related Publications (1)

  • Mikhailova TL, Sishkova E, Poniewierka E, Zhidkov KP, Bakulin IG, Kupcinskas L, Lesniakowski K, Grinevich VB, Malecka-Panas E, Ardizzone S, D'Arienzo A, Valpiani D, Koch M, Denapiene G, Vago G, Fociani P, Zerbi P, Ceracchi M, Camerini R, Gasbarrini G. Randomised clinical trial: the efficacy and safety of propionyl-L-carnitine therapy in patients with ulcerative colitis receiving stable oral treatment. Aliment Pharmacol Ther. 2011 Nov;34(9):1088-97. doi: 10.1111/j.1365-2036.2011.04844.x. Epub 2011 Sep 19.

    PMID: 21929562DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 7, 2009

Study Start

May 1, 2006

Primary Completion

April 1, 2009

Study Completion

December 1, 2009

Last Updated

June 15, 2017

Record last verified: 2009-12

Locations

RU(5)IT(5)LI(2)PL(3)