EUCTR2012-005115-13-ES
Active, not recruiting
Not Applicable
A randomized, assessor-blinded, multicenter, international study investigating efficacy, patient's acceptance, safety and tolerability of Sodium Phosphate tablets compared to split dose Polyethylene Glycol for colon cleansing prior to colonoscopy.
ABORATOIRES MAYOLY SPINDLER0 sites448 target enrollmentJanuary 9, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ABORATOIRES MAYOLY SPINDLER
- Enrollment
- 448
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Written informed consent form.
- •(2\) Men and women aged from 18 to 75 years (included).
- •(3\) Scheduled for a colonoscopy as an outpatient.
- •(4\) Normal renal function (eGFR greater or equal to 60 mL/mn/1\.73m2\)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 224
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 224
Exclusion Criteria
- •(1\) Pregnant woman or likely to be (without contraception) or breast feeding.
- •(2\) Having a disease or condition as follows:
- •\- clinically significant abnormal electrolytes values (sodium, phosphate, potassium, calcium),
- •\- primary hyperparathyroidism associated with hypercalcemia,
- •\- congestive heart failure Class III and IV (Am. Heart Assoc., NYHA Classification),
- •\- unstable angina pectoris or recent myocardial infarction, PTCA or coronary artery bypass surgery within previous 3 months
- •\- ascites,
- •\- known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis,
- •\- inflammatory bowel disease,
- •\- history of gastric stapling or bypass procedure or gastric retention
Outcomes
Primary Outcomes
Not specified
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