Overview

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
sigma-tau i.f.r. S.p.A.
Collaborator:
PRA Health Sciences
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

- Patients treated with L-Carnitine or its esters derivatives during the 3 months
preceding the screening phase.