Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing
NCT ID: NCT01840553
Last Updated: 2014-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
461 participants
INTERVENTIONAL
2013-05-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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polyethylene glycol
4 Liters of PEG administered split in 2 doses
polyethylene glycol
oral sodium phosphate tablets
oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid
oral sodium phosphate tablets
Interventions
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oral sodium phosphate tablets
polyethylene glycol
Eligibility Criteria
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Inclusion Criteria
* Scheduled for a colonoscopy as an outpatient.
* Normal renal function
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Laboratoires Mayoly Spindler
INDUSTRY
Responsible Party
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Locations
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Hôpital Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hopital Edouard Herriot
Lyon, , France
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil, , France
CHU Hotel Dieu
Nantes, , France
Hopital l'Archet
Nice, , France
CHU Cochin
Paris, , France
Clinique Saint-Jean Languedoc
Toulouse, , France
Sana Klinikum Lichtenberg
Berlin, , Germany
Kreisklinik Biberach
Biberach, , Germany
Klinikum Heidenheim
Heidenheim, , Germany
Medizinische Klinik und Poliklinik II Munchen
München, , Germany
Complejo Hospitalario de A Coruna
A Coruña, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de Fuenlabrada
Fuenlabrada, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitarion Gregorio Maranon
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Countries
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References
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Chaussade S, Schmocker C, Toulemonde P, Munoz-Navas M, O'Mahony V, Henri F. Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial. Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18.
Other Identifiers
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2012-005115-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ICOL121
Identifier Type: -
Identifier Source: org_study_id
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