Overview
Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis
Status:
Terminated
Terminated
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)will be investigated.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
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.
- Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed
endoscopically and histologically.
- Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis),
with rectal bleeding sub-score of at least 1.
- Stable background oral aminosalicylates (mesalazine, balsalazide, olsalazine) or
sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening
assessments.
- If female, not pregnant or nursing. For women of childbearing potential, willingness
to avoid a pregnancy during the treatment period and for at least 4 weeks from the
last dose of drug and utilization of an efficient method of birth control for the
entire duration of the trial and until the first menses after a 30-day period after
the last dose of trial medication.
Exclusion Criteria:
- Crohn's disease and indeterminate colitis.
- Current or previous (in the last 10 days preceding the screening) use of systemic
corticosteroids.
- Use of systemic antibiotics in the last 10 days preceding the screening.
- Use of systemic Nonsteroidal anti-inflammatory drugs on a repeat basis in the last 10
days preceding the screening.
- Use of probiotics started within 10 days preceding the screening. A stable regimen
from at least 10 days prior to screening is allowed but the patient must be willing to
continue up to the end of the study.
- Use of immunosuppressants or biological agents within the last 6 weeks preceding the
screening.
- Treatment with L-carnitine or its esters derivatives within the last 3 months.
- Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia,
Campylobacter) or toxins (C.difficile).
- Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed
by the investigator.
- History of colon resection.
- Diverticulitis, symptomatic diverticulosis.
- Active peptic ulcer disease.
- Proctitis (extent of inflammation <15 cm from the anus).
- Bleeding disorders
- Rectal therapy with any therapeutic enemas or suppositories with the exception of
those required for endoscopy during the 10 days preceding the screening.
- Active or chronic infection(s) or malignancies.
- Known hypersensitivity to the active ingredient and excipients of the study drug.