Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment

• Conditions: lcerative Colitis; MedDRA version: 9.1Level: PTClassification code 10009900Term: Colitis ulcerative

• Registration Number: EUCTR2005-003471-20-LT
• Lead Sponsor: SIGMA-TA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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).
One of the following treatments for ulcerative colitis prior to baseline visit:
•Stable background oral aminosalycilates (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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (according to Investigator’s judgement, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified