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Propionyl-L-Carnitine in Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Propionyl-L-Carnitine

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Morgagni - Pierantoni
Ospedale "L. Sacco"
University Federico II
Hospital S. Filippo Neri
Policlinico "A. Gemelli"
Kaunas Medical University Clinic
Vilnius University Santariskiu Hospital
Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1
Samodzielny Publiczny Szpital Kliniczny Nr 3 Katedra i Klinika Gastroenterologii AM
Wojewódzki Szpital Specjalistyczny Klinika Gastroenterologii
Federal State Institution "7-th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia"
Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij"
State Institution "Regional Military Clinical Hospital № 442 named after Z.P. Solovyov of Ministry of Defence of Russia"
Federal State Healthcare Institution "Clinical Hospital № 122 named after L.G. Sokolov of Federal Medical and Biological Agency"
St-Petersburg State Healthcare Institution "Municipal Hospital № 26"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

PLC Colon release tablet 1 g

PLC colon release tablet 2 g

Placebo PLC colon release tablet 2 g

Arm Description

40 patients each arm

Outcomes

Primary Outcome Measures

Disease Activity Index score

Secondary Outcome Measures

Adverse Events

Full Information

NCT ID

NCT01026857

First Posted

December 4, 2009

Last Updated

June 13, 2017

Sponsor

sigma-tau i.f.r. S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01026857

Brief Title

Propionyl-L-Carnitine in Ulcerative Colitis

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

sigma-tau i.f.r. S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PLC Colon release tablet 1 g

Arm Type

Experimental

Arm Description

40 patients each arm

Arm Title

PLC colon release tablet 2 g

Arm Type

Experimental

Arm Description

40 patients each arm

Arm Title

Placebo PLC colon release tablet 2 g

Arm Type

Placebo Comparator

Arm Description

40 patients each arm

Intervention Type

Drug

Intervention Name(s)

Propionyl-L-Carnitine

Other Intervention Name(s)

Dromos

Intervention Description

PLC colon release tablet 1 g/die for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Propionyl-L-Carnitine

Other Intervention Name(s)

Dromos

Intervention Description

PLC colon release tablet 2 g/die for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease Activity Index score

Time Frame

baseline, week 4

Secondary Outcome Measure Information:

Title

Adverse Events

Time Frame

Throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.

Overall Study Officials: