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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Axcan Pharma
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00134758
First received: August 23, 2005
Last updated: July 28, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Adenomatous Polyposis Coli, Familial
Drug: Ursodeoxycholic acid
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficiency of Ursodesoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis Patients. URSOPAF

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • SPIGELMAN severity score of duodenal lesion after 2 years of follow-up [ Time Frame: Baseline, 1 and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cellular proliferation (Ki 67 and PCNA) [ Time Frame: At the baseline, 1 and 2 years ] [ Designated as safety issue: No ]
  • Biliary acid profile [ Time Frame: At the baseline, 1 and 2 years ] [ Designated as safety issue: No ]
  • Compliance to the treatment [ Time Frame: Every 6 months during 2 years ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: October 2004
Estimated Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Delursan
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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134758

Locations
France
Saint-Antoine Hospital
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe Aucan, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT00134758     History of Changes
Other Study ID Numbers: P030419, AOM 03041
Study First Received: August 23, 2005
Last Updated: July 28, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Treatment of adenomas of the duodenum in FAP patients.
Adenoma

Additional relevant MeSH terms:
Adenoma
Adenomatous Polyposis Coli
Adenomatous Polyps
Colonic Diseases
Colonic Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014