Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients

July 28, 2009 updated by: Assistance Publique - Hôpitaux de Paris

Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF

Malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy. Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We designed a randomized double blinded study to evaluate the efficiency of UDCA in the treatment of duodenal adenomas. One hundred patients are planned to be included. Fifty will receive UDCA and fifty a placebo. Three duodenoscopies are planned: one before inclusion, one at the end of the first year of follow-up and one after two years of follow-up at the end of the protocol. These duodenoscopies are associated to endoscopies of the ileal reservoir performed at the time of restorative proctocolectomy and are recorded numerically. Severity of the duodenal adenomas are evaluated according to the SPIGELMAN score. Patients are seen every 6 months. Before each endoscopy, blood samples are collected for biliary acid profile analysis. Moreover, during endoscopies, duodenal fluid and ileal fluid are collected for biliary acid profile analysis, also.

At the end of the follow-up of the last patients included (nov 2008), biliary acid profile analysis will be performed and statistical analysis of the results will be performed.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Saint-Antoine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients between 18 and 65 years of age
  • Weight less than or equal to 100 kg
  • Restorative proctocolectomy
  • Activated protein C (APC) mutation identified or more than 100 polyps on the colectomy specimen
  • SPIGELMAN score of duodenal adenoma greater than or equal to 1
  • Efficient contraceptive treatment for pre-menopausal women
  • Cooperative patient
  • Signed consent
  • Social security insurance

Exclusion Criteria:

  • SPIGELMAN score of duodenal adenoma equal to 4 with severe dysplasia
  • Hepatic disease
  • Intermesenteric desmoid tumour
  • Any severe disease

  • Daily use during the last 3 months of:

    • aspirin;
    • non-steroid anti-inflammatory drugs;
    • tamoxifen;
    • cholestyramine.
  • Pregnancy
  • Breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo

During 2 years :

  • between 40 and 50 kg : 2 tabs/day
  • between 51 and 75 kg : 3 tabs/day
  • between 76 and 100 kg : 4 tabs/day
EXPERIMENTAL: 1

Ursodeoxycholic acid during 2 years :

  • between 40 and 50 kg : 500 mg/day
  • between 51 and 75 kg : 750 mg/day
  • between 76 and 100 kg : 1000 mg/day
Drug: Ursodeoxycholic acid

During 2 years :

  • between 40 and 50 kg : 500 mg/day
  • between 51 and 75 kg : 750 mg/day
  • between 76 and 100 kg : 1000 mg/day
Other Names:
  • Delursan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SPIGELMAN severity score of duodenal lesion after 2 years of follow-up
Time Frame: Baseline, 1 and 2 years
Baseline, 1 and 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cellular proliferation (Ki 67 and PCNA)
Time Frame: At the baseline, 1 and 2 years
At the baseline, 1 and 2 years
Biliary acid profile
Time Frame: At the baseline, 1 and 2 years
At the baseline, 1 and 2 years
Compliance to the treatment
Time Frame: Every 6 months during 2 years
Every 6 months during 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Axcan Pharma

Investigators

  • Principal Investigator: Yann RA Parc, M.D., Ph.D., Department of Digestive Surgery, Saint-Antoine Hospital, Hospital of Paris (AP/HP), Pierre et Marie Curie University, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ANTICIPATED)

October 1, 2009

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (ESTIMATE)

August 25, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2009

Last Update Submitted That Met QC Criteria

July 28, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P030419
  • AOM 03041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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