Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing

A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy

The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.

Inclusion Criteria:

• Men and women aged from 18 to 75 years (included).
• Scheduled for a colonoscopy as an outpatient.
• Normal renal function

Exclusion Criteria:

• Having a disease or condition as follows:

  • repeated episodes of nausea and vomiting
  • abdominal pain due to severe infection or requiring surgery
  • clinically significant abnormal electrolytes values
  • congestive heart failure, unstable angina pectoris or recent myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within previous 3 months
  • known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis,
  • inflammatory bowel disease,
  • history of gastric stapling or bypass procedure or gastric retention

• Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.

• Known allergy to any of the active ingredients or excipients of the study drugs.

• History of phenylketonuria