Status:
COMPLETED
Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing
Lead Sponsor:
Laboratoires Mayoly Spindler
Conditions:
Colon Cleansing
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Men and women aged from 18 to 75 years (included).
- Scheduled for a colonoscopy as an outpatient.
- Normal renal function
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT01840553
Start Date
May 1 2013
End Date
March 1 2014
Last Update
March 24 2014
Active Locations (19)
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1
Hôpital Avicenne
Bobigny, France
2
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
3
Hopital Edouard Herriot
Lyon, France
4
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil, France