Study Results
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Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2006-05-31
2009-12-31
Brief Summary
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Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PLC Colon release tablet 1 g
40 patients each arm
Propionyl-L-Carnitine
PLC colon release tablet 1 g/die for 4 weeks
Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks
PLC colon release tablet 2 g
40 patients each arm
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
Placebo PLC colon release tablet 2 g
40 patients each arm
Placebo
Placebo PLC colon release tablet 2 g/die for 4 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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sigma-tau i.f.r. S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni B. Gasbarrini, M.D.
Role: PRINCIPAL_INVESTIGATOR
Policlinico Universitario "A. Gemelli" - Rome - Italy
Gabriele Bianchi Porro, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ospedale "L. Sacco" - Milan - Italy
Agesilao D'Arienzo, M.D.
Role: PRINCIPAL_INVESTIGATOR
A.O. Universitaria Federico II - Naples - Italy
Daniela Valpiani, M.D.
Role: PRINCIPAL_INVESTIGATOR
P.O. Morgagni Pierantoni - Forlì - Italy
Maurizio Koch, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ospedale "S. Filippo Neri" - Rome - Italy
Ewa Malecka-Panas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1 - Lodz - Poland
Leszek Paradowski, M.D.
Role: PRINCIPAL_INVESTIGATOR
Samodzielny Publiczny Szpital Kliniczny Nr 3 - Wroclaw - Poland
Konrad Lesniakowski, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wojewodzki Szpital - Wroclaw - Poland
Limas Kupcinskas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kaunas Medical University Clinic - Kaunas - Lithuania
Goda Denapiene, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vilnius University Santariskiu Hospital - Vilnius - Lithuania
Vladimir B. Grinevich, M.D.
Role: PRINCIPAL_INVESTIGATOR
State Institution "Regional Military Clinical Hospital N°422 named after Solovyov of Ministry of Defence of Russia - Saint Petersburg - Russia
Elena Sishkova, M.D.
Role: PRINCIPAL_INVESTIGATOR
Federal State Healthcare Institution "Clinical Hospital N°122 named after L.G. Sokolov of Federal Medical and Biological Agency" - Saint Petersburg - Russia
Konstantin P. Zhidkov, M.D.
Role: PRINCIPAL_INVESTIGATOR
St Petersburg State Healthcare Institution "Municipal Hospital N°26" - Saint Petersburg - Russia
Igor G. Bakulin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Federal State Institution "7th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia" - Moscow - Russia
Tatiana L. Mikhailova, M.D.
Role: PRINCIPAL_INVESTIGATOR
Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij" - Moscow - Russia
Locations
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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, , Italy
Kaunas Medical University Clinic
Kaunas, , Lithuania
Vilnius University Santariskiu Hospital
Vilnius, , Lithuania
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, , Poland
Federal State Institution "7-th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia"
Moscow, , Russia
Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij"
Moscow, , Russia
State Institution "Regional Military Clinical Hospital № 442 named after Z.P. Solovyov of Ministry of Defence of Russia"
Saint Petersburg, , Russia
Federal State Healthcare Institution "Clinical Hospital № 122 named after L.G. Sokolov of Federal Medical and Biological Agency"
Saint Petersburg, , Russia
St-Petersburg State Healthcare Institution "Municipal Hospital № 26"
Saint Petersburg, , Russia
Countries
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References
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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.
Other Identifiers
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ST261 DM 01 004
Identifier Type: -
Identifier Source: org_study_id
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