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Sponsored by: |
S.L.A. Pharma AG |
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Information provided by: | S.L.A. Pharma AG |
ClinicalTrials.gov Identifier: | NCT00510692 |
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).
Condition | Intervention | Phase |
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Familial Adenomatous Polyposis Coli FAP |
Drug: Eicosapentanoic 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: Peripheral blood sample |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Two-Arm Chemoprevention Trial in Familial Adenomatous Polyposis Coli Patients Using the Purified Free Fatty Acid, Eicosapentaenoic Acid |
Enrollment: | 63 |
Study Start Date: | November 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2g/day EPA 99%: Active Comparator |
Drug: Eicosapentanoic Acid (EPA)
2 x 500mg EPA capsules twice daily for 6 months
Procedure: 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).
Procedure: Clinical Chemistry
Urea and electrolytes, liver function, clotting profile, and CRP at baseline and month 6.
Procedure: Haematology
Blood count at baseline and month 6.
Procedure: Physical examination
Including cardio-respiratory and abdominal examination at baseline and month 6.
Procedure: Vital signs
Height, weight, heart rate, blood pressure and temperature at baseline and month 6.
Procedure: Urine pregnancy test
For females of child-bearing potential, urine pregnancy test at baseline and month 6.
Procedure: Completion of patient diary card
Subjects are requested to record when doses of study medication are taken and if any new or unusual symptoms are experienced daily for 6 months.
Procedure: Peripheral blood sample
Peripheral blood sample for lipid and resolvin levels at baseline and month 6.
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Placebo: Placebo Comparator |
Procedure: 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).
Procedure: Clinical Chemistry
Urea and electrolytes, liver function, clotting profile, and CRP at baseline and month 6.
Procedure: Haematology
Blood count at baseline and month 6.
Procedure: Physical examination
Including cardio-respiratory and abdominal examination at baseline and month 6.
Procedure: Vital signs
Height, weight, heart rate, blood pressure and temperature at baseline and month 6.
Procedure: Urine pregnancy test
For females of child-bearing potential, urine pregnancy test at baseline and month 6.
Procedure: Completion of patient diary card
Subjects are requested to record when doses of study medication are taken and if any new or unusual symptoms are experienced daily for 6 months.
Procedure: Peripheral blood sample
Peripheral blood sample for lipid and resolvin levels at baseline and month 6.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Middlesex | |
The Polyposis Registry, St. Mark's Hospital, | |
Harrow, Middlesex, United Kingdom, HA1 3UJ |
Principal Investigator: | Nicholas J West, MB BS FRCS | The Polyposis Registry, St. Mark's Hospital, |
Study ID Numbers: | EPA/POL/03 |
Study First Received: | July 30, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00510692 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee |
Eicosapentaenoic Acid EPA EPA 99% Fatty acid omega-3 apoptosis cell proliferation colonic mucosa |
polyp Familial Adenomatous Polyposis Coli FAP resolvin Ileo-rectal anastomosis IRA PUFA Endoscopy |
Familial adenomatous polyposis Digestive System Neoplasms Adenomatous Polyposis Coli Gastrointestinal Diseases Colonic Diseases Familial polyposis Polyps Intestinal Diseases Intestinal Neoplasms |
Neoplastic Syndromes, Hereditary Digestive System Diseases Genetic Diseases, Inborn Gastrointestinal Neoplasms Adenoma Colonic Neoplasms Adenomatous Polyps Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Intestinal Polyposis Neoplasms by Site Neoplasms by Histologic Type |