A Phase 2/3 interventional study of Eicosapentaenoic Acid (EPA) and Endoscopy in Adenomatous Polyps, sponsored by S.L.A. Pharma AG. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-17.
Sponsored by S.L.A. Pharma AG · Phase 2/3, Interventional, and Treatment
The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.
Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps. More than 90% of new large bowel cancers arise sporadically. The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation (formation of new cells) and apoptosis (natural cell death) from changes in the genes involved in normal colon cells.
Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA).
Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.
79 studies on the registry are indexed under Adenomatous Polyps; 9 are open to participants now.
This study's planned enrollment of 120 is below the median of 208 across 52 interventional studies indexed under Adenomatous Polyps.
Browse Adenomatous Polyps studies →S.L.A. Pharma AG is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Eicosapentaenoic Acid (EPA) · Procedure: Endoscopy · Procedure: Biopsies taken · Procedure: Clinical chemistry · Procedure: Haematology · Procedure: Physical examination · Procedure: Vital signs · Procedure: Urine pregnancy test · Procedure: Completion of patient diary card
Drug: Eicosapentaenoic Acid (EPA) · Procedure: Endoscopy · Procedure: Biopsies taken · Procedure: Clinical chemistry · Procedure: Haematology · Procedure: Physical examination · Procedure: Vital signs · Procedure: Urine pregnancy test · Procedure: Completion of patient diary card
Procedure: Endoscopy · Procedure: Biopsies taken · Procedure: Clinical chemistry · Procedure: Haematology · Procedure: Physical examination · Procedure: Vital signs · Procedure: Urine pregnancy test · Procedure: Completion of patient diary card
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)
Also known as: ALFA
At baseline, month 3 and month 6.
Also known as: Colonoscopy, Flexible sigmoidoscopy
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.
Full blood count at baseline, month 3 and month 6.
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
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.
To measure levels of apoptosis in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
Time frame: 3 months and 6 months
To measure levels of cell proliferation in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
Time frame: 3 months and 6 months
To measure the tissue content of EPA in the colonic mucosa before, during and after treatment with EPA.
Time frame: 3 months and 6 months
To determine the safety and tolerability of EPA.
Time frame: 3 months and 6 months
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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S.L.A. Pharma AG