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Ulcerative ColitisPhase 2NCT01026857

Propionyl-L-Carnitine in Ulcerative Colitis

A Phase 2 study testing Propionyl-L-Carnitine in people with Ulcerative Colitis, run by sigma-tau i.f.r. S.p.A. at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Propionyl-L-Carnitine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
15 sitesin 4 countries
Study dates
May 2006to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

Italy5 sites

  • Hospital Morgagni - Pierantoni

    Forlì, 47100

  • Ospedale "L. Sacco"

    Milan, 20157

  • University Federico II

    Naples, 80131

  • Hospital S. Filippo Neri

    Rome, 00135

  • Policlinico "A. Gemelli"

    Rome, 00168

Other trials in Italy

Russia5 sites

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

    Moscow, 107014

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

    Moscow, 123154

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

    Saint Petersburg, 193163

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

    Saint Petersburg, 194291

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

    Saint Petersburg, 196247

Other trials in Russia

Poland3 sites

  • Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1

    Lodz, 90-153

  • Samodzielny Publiczny Szpital Kliniczny Nr 3 Katedra i Klinika Gastroenterologii AM

    Wroclaw, 50-326

  • Wojewódzki Szpital Specjalistyczny Klinika Gastroenterologii

    Wroclaw, 51-149

Other trials in Poland

Lithuania2 sites

  • Kaunas Medical University Clinic

    Kaunas, 50009

  • Vilnius University Santariskiu Hospital

    Vilnius, 08661

Other trials in Lithuania

About this study

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

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).

Read the 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.

Being tested
Propionyl-L-Carnitine, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Propionyl-L-CarnitineDrug

    Also called Dromos

    PLC colon release tablet 1 g/die for 4 weeks

  • Propionyl-L-CarnitineDrug

    Also called Dromos

    PLC colon release tablet 2 g/die for 4 weeks

  • PlaceboDrug

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

Study groups in NCT01026857
Study groupRoleWhat they receive
PLC Colon release tablet 1 gExperimental40 patients each arm
Receives: Drug: Propionyl-L-Carnitine; Drug: Placebo
PLC colon release tablet 2 gExperimental40 patients each arm
Receives: Drug: Propionyl-L-Carnitine; Drug: Placebo
Placebo PLC colon release tablet 2 gPlacebo comparator40 patients each arm
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Activity Index score

    Measured: baseline, week 4

Secondary outcomes (1)

  1. Adverse Events

    Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2009 (estimated)
  2. Study startMay 2006
  3. Primary completionApr 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01026857
Sponsor's protocol ID
ST261 DM 01 004
Status last verified
Dec 2009
First submitted
4 Dec 2009
Last updated
15 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21929562

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propionyl-L-Carnitine in people with Ulcerative Colitis, run by sigma-tau i.f.r. S.p.A. at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Italy, Russia, Poland, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Activity Index score (time frame: baseline, week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01026857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.

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