Clinical Trials Logo

Clinical Trial Summary

2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.


Clinical Trial Description

The purpose of this Phase III study is to determine whether Eicosapentaenoic acid-free fatty acid is a safe and well tolerated treatment in reducing the number of polypectomies FAP patients with an APC gene mutation have over a 2 year treatment period and to assess the effect that this has on clinical disease progression. Planned Sample Size This study will enrol 204 subjects (102 subjects per treatment group). Primary Objective is to determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy. Secondary objectives is to evaluate the clinical disease progression and the long-term safety and tolerability of EPA-FFA. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03806426
Study type Interventional
Source S.L.A. Pharma AG
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 5, 2018
Completion date July 31, 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05630794 - Testing ONC201 to Prevent Colorectal Cancer Phase 1
Completed NCT02961374 - Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer Phase 2
Completed NCT01483144 - Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Completed NCT00641147 - Curcumin in Treating Patients With Familial Adenomatous Polyposis Phase 2
Recruiting NCT03471403 - Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Not yet recruiting NCT04531930 - Colorectal Adenoma Canceration in FAP
Recruiting NCT04677998 - A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Recruiting NCT04678011 - A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Completed NCT00927485 - Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP) N/A
Recruiting NCT00253812 - Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy N/A
Withdrawn NCT00248053 - Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients Phase 2
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research
Completed NCT04674228 - Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01
Completed NCT01656746 - Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease N/A
Completed NCT00808743 - Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis Phase 2/Phase 3
Active, not recruiting NCT03847636 - CryoBalloon Ablation for Treatment of Duodenal Adenomas N/A
Not yet recruiting NCT05112822 - Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP) Phase 1
Recruiting NCT02656134 - Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP) N/A
Withdrawn NCT01245816 - A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Recruiting NCT04709445 - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses N/A