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Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA

NCT00510692 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-08-22

Study results available
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Summary

This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).

Conditions

  • Familial Adenomatous Polyposis Coli
  • FAP

Interventions

DRUG

Eicosapentanoic Acid (EPA)

2 x 500mg EPA capsules twice daily for 6 months

PROCEDURE

Endoscopy

Endoscopy with video and photographs at baseline and month 6.

PROCEDURE

Biopsies taken

9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).

DRUG

Placebo

2 x 500mg placebo capsules twice daily for 6 months

Sponsors & Collaborators

  • S.L.A. Pharma AG

    lead INDUSTRY

Principal Investigators

  • Nicholas J West, MB BS FRCS · The Polyposis Registry, St. Mark's Hospital,

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United Kingdom

Study Locations

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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 NCT00510692 on ClinicalTrials.gov