Phase II, Open, Monocenter Study to investigate the efficacy of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Inflammatory Bowel Disease (IBD) under Oral Stable Treatment - ND

• Conditions: IBD; MedDRA version: 9.1Level: PTClassification code 10011401; MedDRA version: 9.1Level: LLTClassification code 10045282

• Registration Number: EUCTR2009-013680-19-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Have read the Information for the Patient and signed the Informed Consent Form. 2. Age comprised between 18 and 80 inclusive. 3. If female, not pregnant or nursing. 4. 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. 5. Availability of a pancolonoscopy and histology both confirming the diagnosis of active inflammatory bowel disease. 6. Disease Activity Index comprised between 3 and 10, inclusive, (mild to moderate ulcerative colitis). 7. Be under therapy with one of the following treatments for IBD prior to baseline visit: a) Stable background oral aminosalycilates (mesalazine, balsalazide, olsalazine) or sulfasalazine therapy for greater than or equal to 2 weeks prior to baseline assessments. b) Stable background mercaptopurine or azathioprine for greater than or equal to 3 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

1. First diagnosis of IBD. 2. Crohns disease (only ileal). 3. Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids. 4. Use of antibiotics in the last 7 days preceding the screening. 5. Use of NSAIDs in the last 7 days preceding the screening. 6. Positive stool culture (when performed, according to Investigators judgment, to assess possible parasitologic infection(s)). 7. Significantly impaired liver, renal, pulmonary or cardiovascular function. 8. History of colon resection. 9. Active or chronic infection(s). 10. Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study. 11. 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