IBD MedDRA version: 9.1 Level: PT Classification code 10011401 MedDRA version: 9.1 Level: LLT Classification code 10045282
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetylcarnitine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the clinical/endoscopic and histological activity of a colon-release tablet formulation of Propionyl L-Carnitine at the dosage of 2g/die in patients affected by mild to moderate Inflammatory Bowel Disease under oral stable treatment(s).The level of activity will be used to design future randomized controlled trials.;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of PLC.;Primary end point(s): The primary study endpoint will be the clinical/endoscopic response defined as a lowering of the Disease Activity Index (DAI score-see appendix II) of at least 3 points or the reaching of remission defined as a DAI score ≤ 2 with no individual subscore >1. | — |
Countries
Italy
Outcome results
None listed