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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
Axcan Pharma
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: August 23, 2005
Last updated: July 28, 2009
Last verified: July 2009
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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

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

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00134758

Saint-Antoine Hospital
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Axcan Pharma
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christophe Aucan, Department of clinical research and development Identifier: NCT00134758     History of Changes
Other Study ID Numbers: P030419
AOM 03041
Study First Received: August 23, 2005
Last Updated: July 28, 2009

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents processed this record on April 28, 2017