120
Participants
Start Date
October 31, 2006
Primary Completion Date
June 30, 2008
Study Completion Date
June 30, 2008
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)
Endoscopy
At baseline, month 3 and month 6.
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.
Clinical chemistry
Full blood count at baseline, month 3 and month 6.
Haematology
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Physical examination
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Vital signs
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
Urine pregnancy test
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
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.
S. Orsola Hospital, Bologna
St. George's Hospital Medical School, London
S.L.A. Pharma AG
INDUSTRY