Colon Cleansing
Conditions
Brief 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.
Interventions
DRUGoral sodium phosphate tablets
DRUGpolyethylene glycol
Sponsors
Laboratoires Mayoly Spindler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall quality of bowel cleansing | day 1 |
Countries
France, Germany, Spain
Outcome results
None listed