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

NCT01567956 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-11-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Propionyl-L-Carnitine

500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks

DRUG

Placebo

500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • sigma-tau i.f.r. S.p.A.

    lead INDUSTRY

Principal Investigators

  • Sandro Ardizzone, MD · Head of Inflammatory Bowel Diseases Unit Hospital "Luigi Sacco" Milan - ITALY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-10-31
Completion
2014-01-31

Countries

  • Austria
  • France
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567956 on ClinicalTrials.gov