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

Mayoly Spindler

Status and phase

Completed

Phase 3

Conditions

Colon Cleansing

Treatments

Drug: oral sodium phosphate tablets

Drug: polyethylene glycol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01840553

2012-005115-13 (EudraCT Number)

ICOL121

Details and patient eligibility

About

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.

Enrollment

461 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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