A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing
Condition: Colon Cleansing in Preparation for Colonoscopy
Intervention: FE 999169; Niflec
Intervention description: FE 999169 is a white crystalline powder for oral solution. Each sachet (16.1 g) contains sodium picosulfate hydrate 10 mg, magnesium oxide 3.5 g and anhydrous citric acid 12 g as well as orange flavour, potassium bicarbonate and sodium saccharin as excipients. FE 999916 is dissolved by mixing the contents of the sachet with approximately 150mL of cold water in a cup before administration.; Niflec is a white-yellowish powder for oral solution. Each plastic sachet (137.155 g) contains sodium chloride 2.93 g, potassium chloride 1.485 g, sodium bicarbonate 3.37 g and sodium sulfate anhydrous 11.37 g, as well as macrogol 4000, saccharin sodium hydrate, flavour as excipients. Niflec is dissolved in water to make approximately 2 L of solution before administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 637.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day
      before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing
      Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule"
      in subjects requiring colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients, age 20 to 80 years inclusive, requiring colonoscopy

          -  Female patients should be post-menopausal (women ≥45 years with no menstrual period
             for at least 12 months without an alternative medical cause), or be surgically
             sterile, or be using medically approved contraception, throughout the trial period.

          -  Fertile female patients must have a confirmed negative pregnancy test at screening and
             randomization

          -  Patients must have had more than or equal to 3 spontaneous bowel movements per week
             prior to the colonoscopy

          -  Written informed consent obtained prior to any study-related procedure

        Exclusion Criteria:

          -  Acute surgical abdominal conditions, such as acute intestinal obstruction or
             intestinal perforation, diverticulitis, appendicitis. If intestinal obstruction and
             perforation are suspected, perform appropriate diagnostic studies to rule out these
             conditions

          -  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, idiopathic
             pseudo-obstruction, hypomotility syndrome)

          -  Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis,
             ileus)

          -  Ascites.

          -  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 (any of the serum creatinine, or serum potassium value exceeding
             the upper limits of the normal range at screening) or a history of this event

          -  Participation in any other clinical trial during the past 3 months

          -  Any clinically significant laboratory value at screening, including pre-existing
             electrolyte abnormality, based on clinical history that the investigators feel may
             affect the study evaluation

          -  Hypersensitivity to active ingredients

          -  Subject who cannot suspend the prohibited medications

          -  Subjects not appropriate to participate in the study as deemed by the investigator