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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Mayoly Spindler

Criteria

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