Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
Condition: Bowel Preparation
Intervention: PicoPrep; HalfLytely; bisacodyl
Intervention description: PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids.; HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.; Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
Intervention MeSH terms: Bisacodyl; Picosulfate sodium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 608.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Bowel Preparation; Colonoscopy

Summary:

      Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:
      2-sachets for oral solution in two divided doses given a night before (first dose - sachet)
      and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral
      solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its
      effectiveness, tolerability and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective
             colonoscopy

          -  Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for
             at least 12 months without an alternative medical cause), be surgically sterile, or be
             using medically approved contraception, throughout the trial period

          -  Females of childbearing potential must undergo a pregnancy test at screening and again
             at randomization

          -  Subjects must have had more than or equal to 3 spontaneous bowel movements per week
             for one month prior to the colonoscopy

          -  Subjects should be willing, able and competent to complete the entire procedure and to
             comply with study instructions

          -  Written informed consent obtained prior to study

        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, hemorrhoid surgery or prior
             endoscopic procedures

          -  Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic
             pseudo-obstruction, hypomotility syndrome)

          -  Ascites

          -  Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis,
             ileus)

          -  Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)

          -  Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive
             Heart Failure (CHF), or uncontrolled hypertension

          -  Renal insufficiency (serum creatinine and potassium must be within normal limits)

          -  Participation in an investigational study within 30 days prior to receiving study
             medication (or within 60 days for investigational drugs with an elimination half-life
             greater than 15 days)

          -  Any clinically significant laboratory value at the screening, including pre-existing
             electrolyte abnormality, based on clinical history that the Investigator feels may
             affect the study evaluation

          -  Hypersensitivity to active ingredients