Propionyl-L-Carnitine in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026857
• Other study ID #: ST261 DM 01 004
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2009
• Last updated: June 13, 2017
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: sigma-tau i.f.r. S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Propionyl-L-Carnitine
PLC colon release tablet 1 g/die for 4 weeks
• Propionyl-L-Carnitine
PLC colon release tablet 2 g/die for 4 weeks
• Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks

Locations

Country	Name	City	State
Italy	Hospital Morgagni - Pierantoni	Forlì
Italy	Ospedale "L. Sacco"	Milan
Italy	University Federico II	Naples
Italy	Hospital S. Filippo Neri	Rome
Italy	Policlinico "A. Gemelli"	Rome
Lithuania	Kaunas Medical University Clinic	Kaunas
Lithuania	Vilnius University Santariskiu Hospital	Vilnius
Poland	Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1	Lodz
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 3 Katedra i Klinika Gastroenterologii AM	Wroclaw
Poland	Wojewódzki Szpital Specjalistyczny Klinika Gastroenterologii	Wroclaw
Russian Federation	Federal State Institution "7-th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia"	Moscow
Russian Federation	Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij"	Moscow
Russian Federation	Federal State Healthcare Institution "Clinical Hospital ? 122 named after L.G. Sokolov of Federal Medical and Biological Agency"	Saint Petersburg
Russian Federation	St-Petersburg State Healthcare Institution "Municipal Hospital ? 26"	Saint Petersburg
Russian Federation	State Institution "Regional Military Clinical Hospital ? 442 named after Z.P. Solovyov of Ministry of Defence of Russia"	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
sigma-tau i.f.r. S.p.A.

Countries where clinical trial is conducted

Italy,  Lithuania,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Index score		baseline, week 4
Secondary	Adverse Events		Throughout the study