A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Condition: Bowel Preparation
Intervention: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution; Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
Intervention description: Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.; Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Intervention MeSH terms: Picosulfate sodium; Magnesium Oxide; Sodium Citrate; Citric Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 917.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous
      Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing
      colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled
             to undergo elective colonoscopy

          -  Females of childbearing potential must agree to use an adequate contraception during
             the course of the trial. Accepted forms of contraception are: i.e., implants,
             injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual
             abstinence, and vasectomized sexual partner. Premenopausal women who are of
             childbearing potential must have a negative serum pregnancy test result at screening
             and a negative urine pregnancy test result at randomization prior to colonoscopy. In
             the case of oral contraceptive use, women should have been taking the same pill
             consistently for a minimum of twelve (12) weeks before taking study medication.
             Sterilized or postmenopausal women may also participate. Women are considered to be
             postmenopausal and are not considered to be of childbearing potential if they have had
             twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical
             profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical
             bilateral oophorectomy (with or without hysterectomy) or tubal ligation.

          -  An average of at least 3 spontaneous bowel movements per week for one month prior to
             the colonoscopy

        Exclusion Criteria:

          -  Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric
             retention

          -  Acute intestinal or gastric ulceration

          -  Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon

          -  Undergoing colonoscopy for foreign body removal or decompression

          -  Reduced level of consciousness or inability to swallow without aspiration

          -  Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior
             endoscopic procedures

          -  Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)

          -  Uncontrolled angina and/or myocardial infarction (MI) within last three months,
             congestive heart failure (CHF), uncontrolled hypertension, or ascites

          -  Severely reduced renal function (<30 mL/min/1.73 m2)

          -  Pregnant or lactating women

          -  Any clinically relevant abnormal findings in medical history, physical examination,
             vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at
             Screening Visit 1

          -  Rhabdomyolysis

          -  Chronic nausea and vomiting

          -  Hypermagnesemia

          -  Undergoing treatment with Lithium