Clinical trial NCT01840553: Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing
Official title: A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cleansing
Lead sponsor: Laboratoires Mayoly Spindler
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* Men and women aged from 18 to 75 years (included).
* Scheduled for a colonoscopy as an outpatient.
* Normal renal function

Exclusion Criteria:

* 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

Primary outcomes:
measure: overall quality of bowel cleansing
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Montfermeil
country: France
facility: Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Nice
country: France
facility: Hopital l'Archet
city: Paris
country: France
facility: CHU Cochin
city: Toulouse
country: France
facility: Clinique Saint-Jean Languedoc
city: Berlin
country: Germany
facility: Sana Klinikum Lichtenberg
city: Biberach
country: Germany
facility: Kreisklinik Biberach
city: Heidenheim
country: Germany
facility: Klinikum Heidenheim
city: Munchen
country: Germany
facility: Medizinische Klinik und Poliklinik II Munchen
city: A Coruna
country: Spain
facility: Complejo Hospitalario de A Coruna
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitarion Gregorio Maranon
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
Study officials:
References:
citation: 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.