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.