A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

Study Overview
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Brief Summary
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This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.

Official Title
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A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

Conditions
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Bowel Cleansing

Intervention / Treatment
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* Drug: PICOPREP


Participation Criteria
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Eligibility Criteria
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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 (ATC code A06AC)) per week for one month prior to the colonoscopy 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: Transdermal patch Hormonal contraception (i.e., oral, implant, or injectable contraceptive) Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.) Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy Sexual abstinence The subject is a breast-feeding or lactating woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PICOPREP day-before dosing schedule<br>Both doses administered the day before colonoscopy. | Drug: PICOPREP<br>* Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution<br>|
| Experimental: PICOPREP tailored dosing schedule<br>First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy. | Drug: PICOPREP<br>* Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale | Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). | Day 1 (day of colonoscopy) | 
| Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale | Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid). | Day 1 (day of colonoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascending Colon Cleansing Responder Status (ITT) | Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules. | Day 1 (day of colonoscopy) | 
| Frequency and Intensity of Adverse Events |  | From baseline (screening) up to day 10 after colonoscopy | 
| Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure) | Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic). | From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit) | 
| Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) | Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory. | From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit) |