Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2014
Interventions
- Drug: oral sodium phosphate tablets
- Drug: polyethylene glycol
Arms, Groups and Cohorts
- Active Comparator: polyethylene glycol
- 4 Liters of PEG administered split in 2 doses
- Experimental: oral sodium phosphate tablets
- oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid
Clinical Trial Outcome Measures
Primary Measures
- overall quality of bowel cleansing
- Time Frame: day 1
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Laboratoires Mayoly Spindler
- Provider of Information About this Clinical Study
- Sponsor
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