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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Familial Adenomatous Polyposis ColiFAP
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

Trial Locations (1)

HA1 3UJ

The Polyposis Registry, St. Mark's Hospital,, Harrow

All Listed Sponsors
lead

S.L.A. Pharma AG

INDUSTRY

NCT00510692 - Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Using EPA | Biotech Hunter | Biotech Hunter