Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Adenomatous Polyps
Interventions
DRUG

Eicosapentaenoic Acid (EPA)

Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)

PROCEDURE

Endoscopy

At baseline, month 3 and month 6.

PROCEDURE

Biopsies taken

9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.

PROCEDURE

Clinical chemistry

Full blood count at baseline, month 3 and month 6.

PROCEDURE

Haematology

Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.

PROCEDURE

Physical examination

Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.

PROCEDURE

Vital signs

Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.

PROCEDURE

Urine pregnancy test

For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.

PROCEDURE

Completion of patient diary card

Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.

Trial Locations (2)

40138

S. Orsola Hospital, Bologna

SW17 0RE

St. George's Hospital Medical School, London

All Listed Sponsors
lead

S.L.A. Pharma AG

INDUSTRY

NCT00432913 - Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa | Biotech Hunter | Biotech Hunter