E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sporadic colonic adenomata |
|
MedDRA Classification |
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 |
To measure levels of apoptosis and cell proliferation in patients with a history of colonic adenomas, before and after treatment with EPA. |
|
E.2.2 | Secondary objectives of the trial |
To measure the uptake of EPA into the colonic mucosa after treatment.
To determine the safety and tolerability of EPA.
To assess COX-1 and COX-2 expression in the colonic mucosa before and after treatment with EPA. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
To qualify for inclusion in this study, the participant must satisfy all of the criteria listed below: • Males or females aged over 18 • Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards. • Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards. • Patients must have a known history of colorectal adenomata and be under clinical follow-up for these, or be found to have one or more of these at the time of colonoscopy. • Patients must have provided written informed consent to participate
|
|
E.4 | Principal exclusion criteria |
The patient will be excluded from the study for any of the following reasons: • Patients who are allergic to fish • Patients who have diabetes mellitus • Patients who are pregnant or breast-feeding • Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis • Patients who have aspirin-sensitive asthma • Patients suffering from haemorrhagic disorders • Patients who are taking warfarin or other anticoagulants • Patients who have significant abnormalities on their screening blood tests • Patients taking lipid lowering medication • Patients with known inflammatory bowel disease (IBD), or previously unknown IBD until discovered at the time of their colonoscopy • Patients with gastrointestinal malabsorptive disease • Patients belonging to a known polyposis syndrome (e.g. FAP, HNPCC) • Patients with a previous colonic resection for colorectal cancer • Patients who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study • Patients who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia • Patients with a history of alcohol or drug abuse, including laxative abuse • Patients considered by their physician unlikely to be able to comply with the protocol. • Patients who have taken part in an experimental drug study in the preceding 2 months
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Within-patient changes in markers of cell proliferation and apoptosis between baseline and the 3 month and 6 month timepoints will be determined and compared across the three treatment groups. |
|
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 | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Measurement of physiological changes as index of potential prophylactic effect |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
|
The clinical phase of the study will be defined by the last visit of the last patient. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |