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.

• Conditions: Bowel cleansing to ensure the preparation of patient prior to colonic surgery or colon endoscopic or radiological diagnostic procedures; MedDRA version: 14.1Level: PTClassification code 10066943Term: Bowel preparationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-005115-13-ES
• Lead Sponsor: ABORATOIRES MAYOLY SPINDLER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-09
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 448

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
- history of colonic resection, except partial resection of the sigmoid
- severe chronic constipation (< 2 bowel movements per week)
- swallowing difficulties
- any other clinical condition which, in the opinion of the investigator, would not allow the subject to participate in the study in good conditions.
(3) Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.
(4) Drugs that affect renal perfusion or function, including diuretics, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptors blockers or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) (occasional NSAIDs use is permitted) initiated within 4 weeks prior to first study drug intake,
(5) Concomitant use of medications known to prolong the QT interval.
(6) Known allergy to any of the active ingredients or excipients of the study drugs.
(7) History of phenylketonuria
(8) Subjects who have participated in a clinical trial in the previous 30 days.
(9) Subjects deprived of freedom by judicial or administrative decision, hospitalized without their consent or for other reasons than the research, under legal protection or unable to express their consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified