E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Split dose bowel cleansing for colonoscopy |
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E.1.1.1 | Medical condition in easily understood language |
Bowel preparation for colonoscopy |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 |
This randomized controlled trial is designed to test the hypothesis that split-dosing low-volume polyethylene-glycol solution can increase the adenoma detection in patients undergoing screening colonoscopy |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
asymptomatic subjects aged 50-69 participating to regional screening program and undergoing outpatient colonoscopy for positive immunologic fecal occult blood test |
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E.4 | Principal exclusion criteria |
- patients undergoing colonoscopy as primary screening test - patients undergoing colonoscopy for symptoms or post-polipectomy/ cancer surveillance - patients with history of negative large bowel endoscopy within the previous 5 years - patients with personal history of hereditary syndromes – FAP, HNPCC - patients with history of colonic resection and inflammatory bowel disease - patients with a history of radiation therapy to abdomen or pelvis - patients with a history of severe cardiovascular, pulmonary, liver or renal disease - patients with unstable psychiatric illness - patients at risk for inhalation - patients on ant-platelet therapy or anticoagulation at the time of endoscopy procedure, preventing polyp resection - patient with known hypersensitivity or contraindications (i.e., patients with phenylketonuria or glucose-6-phosphate dehydrogenase deficiency) to the study product - patients who are not able or refuse to provide informed written consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with at least one adenoma (adenoma detection rate) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Overall quality of bowel preparation, as assessed by the endoscopists by the Harefield Cleansing Scale (HCS) - Quality of bowel preparation for the right colon - Proportion of patients with at least one advanced adenoma (adenoma > 10mm, and/or villous component, and/or high grade dysplasia) - Proportion of patients with at least one flat/depressed adenoma, according to Paris classification - Proportion of patients with at least one proximal sessile serrated adenoma/polyp - Number of total adenomas, advanced adenomas, proximal adenomas, proximal advanced adenomas, flat/depressed adenomas - Patient tolerability and acceptability, as assessed by a nurse before colonoscopy |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | No |
E.8.1.5 | Parallel group | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | |