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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2015

Interventions

  • Drug: PICOPREP
    • Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution

Arms, Groups and Cohorts

  • Active Comparator: PICOPREP day-before dosing schedule
    • Both doses administered the day before colonoscopy.
  • Experimental: PICOPREP tailored dosing schedule
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
    • Time Frame: Day 1 (day of colonoscopy)
    • 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).
  • Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
    • Time Frame: Day 1 (day of colonoscopy)
    • 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).

Secondary Measures

  • Ascending Colon Cleansing Responder Status (ITT)
    • Time Frame: Day 1 (day of colonoscopy)
    • 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.
  • Frequency and Intensity of Adverse Events
    • Time Frame: From baseline (screening) up to day 10 after colonoscopy
  • Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)
    • Time Frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
    • Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).
  • Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)
    • Time Frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
    • 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.

Participating in This Clinical Trial

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: 1. Transdermal patch 2. Hormonal contraception (i.e., oral, implant, or injectable contraceptive) 3. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.) 4. Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy 5. Sexual abstinence – The subject is a breast-feeding or lactating woman

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ferring Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Development Support, Study Director, Ferring Pharmaceuticals

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