Propionyl-L-Carnitine in Ulcerative Colitis

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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:

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.