E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Barrett's oesophagus refers to changes in the lining of the lower oesophagus in response to injury caused by gastric reflux. It is a pre-malignant condition and has a well established link with adenocarcinoma of the oesophagus which is increasing in frequency in western countries. Although not everyone will progress to cancer, there is as yet no established medical therapy which will reverse the process. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004134 |
E.1.2 | Term | Barrett's esophagus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004136 |
E.1.2 | Term | Barrett's oesophagitis with dysplasia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Polyunsaturated omega 3 fatty acids (PUFA) found in fish oils have been shown to be of benefit in certain conditions, for example cardiovascular disease and colorectal cancer.We are investigating the effect of such a PUFA, specifically eicosanopentanoic acid (EPA), on Barrett's oesophagus and its effects on progression of dysplasia a precursor to malignancy.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Any patient, male or female, aged 18+ undergoing endoscopic surveillance for Barrett's oesophagus.
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E.4 | Principal exclusion criteria |
. Patients who are allergic to fish (cannot take tablets) · Pregnant or breast-feeding patients (although there is no known harm associated with the capsules we are not keen to give them to pregnant people in case of unknown harmful effects) . Patients with a bleeding diathesis/disorder · Patients who are taking warfarin or other anticoagulants (excluding aspirin) - (EPA can interact with warfarin and increase bleeding risk) . Patients with known gastrointestinal malabsorption · Patients with known dysplasia at previous endoscopy · Patients who are taking other fish-oil supplements (eg cod liver oil) who are unwilling to stop them for the duration of the study · Patients deemed mentally incompetent. · Patients considered by their physician unlikely to be able to comply with the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
This is a pilot study looking at the effects of EPA on Barrett cell apoptosis (programmed cell death), abnormal cell proliferation and levels of the enzyme ornithine decarboxylase which are markers of progression to Barrett cell dysplasia, a precursor of malignancy We will use three laboratory 'markers' which have been shown to be altered in Barrett's oesophagus and cancer in general. Apoptosis or programmed cell death is a process whereby cells die as part of their normal function. Apoptosis has been shown to be reduced in cancers, including that of the oesophagus. Abnormal cellular proliferation may play a role in the development of abnormal cells, and it has been shown previously that using the antibody we will be using,(Ki-67), the proliferation is higher in Barrett's with dysplasia and cancer than in Barrett's without these changes. Finally the level of an enzyme called ornithine decarboxylase has been shown to be higher in those Barrett's patients who have dysplasia than those without.
The aim of this study is to treat patients with EPA and measure these 3 parameters to test the hypothesis that EPA influences these 3 markers favourably and may therefore represent a novel therapy to reduce the risk of a patient with Barrett's oesophagus developing cancer of the oesophagus.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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This is a pilot study looking at 15 patients only so it is not anticipated there will be a need to stop the study before completion |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |