E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066943 |
E.1.2 | Term | Bowel preparation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
To demonstrate non-inferiority of a tailored PICOPREP dosing schedule compared to the day-before PICOPREP dosing schedule in overall colon cleansing in preparation for colonoscopy |
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E.2.2 | Secondary objectives of the trial |
• To demonstrate the efficacy of ascending, mid (transverse, descending) and recto-sigmoid colon cleansing of a tailored PICOPREP dosing schedule
• To demonstrate convenience and satisfaction of a tailored PICOPREP dosing schedule compared to the day-before PICOPREP dosing schedule
• To demonstrate the impact of a tailored PICOPREP dosing schedule compared to the day-before PICOPREP dosing schedule on health economics
• To evaluate safety and tolerability through the collection of adverse events (AEs), clinical laboratory tests and vital signs
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy
•Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ACT code A06AC)) per week for one month prior to the colonoscopy |
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E.4 | Principal exclusion criteria |
• Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
• Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
• Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
• Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
• Ascites
• Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
• Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
• Severely reduced renal function (Glomerular filtration rate (GFR) <30 (mL/min/1.73 m2))
• The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:
a.Transdermal patch
b.Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
c.Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
d.Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
e.Sexual abstinence
• The subject is a breast-feeding or lactating woman |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Overall colon cleansing procedure measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During colonoscopy at visit 3 |
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E.5.2 | Secondary end point(s) |
Key Secondary endpoint:
•Ascending colon cleansing by percentage of subjects classified as success , i.e. excellent or good, measured by the Ottawa Scale at Visit 3 performed by a colonoscopist blinded to the dosing schedules
Safety:
•Frequency and intensity of adverse events
•Clinically significant changes in vital signs (pulse, blood pressure [BP])
•Clinically significant changes in laboratory values
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints for the secondary end points:
Visit 3
Safety:
AEs collected at all visits and telephone contact
Vital signs measured at all visits
Lab parameters measured at visit 1,3 and 4 |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | Yes |
E.8.2.3.1 | Comparator description |
PICOPREP day-before dosing schedule |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |