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Clinical Trials/EUCTR2012-005115-13-ES
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.

Registry
who.int
Start Date
January 9, 2013
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ABORATOIRES MAYOLY SPINDLER

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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