A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
Condition: Bowel Cleansing
Intervention: PICOPREP
Intervention description: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Intervention MeSH terms: Picosulfate sodium
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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