Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing

Phase 3

Completed

• Conditions: Colon Cleansing
• Interventions: Drug: oral sodium phosphate tablets; Drug: polyethylene glycol

• Registration Number: NCT01840553
• Lead Sponsor: Laboratoires Mayoly Spindler

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Study Start: 2013-05
• Status Verified: 2013-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 461

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral sodium phosphate tablets	oral sodium phosphate tablets	oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid
polyethylene glycol	polyethylene glycol	4 Liters of PEG administered split in 2 doses

Primary Outcome Measures

Name	Time	Method
overall quality of bowel cleansing	day 1

Trial Locations

Locations (19)

Hôpital Avicenne; 🇫🇷 Bobigny, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Complejo Hospitalario de A Coruna; 🇪🇸 A Coruna, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Medizinische Klinik und Poliklinik II Munchen; 🇩🇪 Munchen, Germany

Hospital de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil; 🇫🇷 Montfermeil, France

Klinikum Heidenheim; 🇩🇪 Heidenheim, Germany

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Clinique Saint-Jean Languedoc; 🇫🇷 Toulouse, France

Hopital l'Archet; 🇫🇷 Nice, France

CHU Hotel Dieu; 🇫🇷 Nantes, France

Sana Klinikum Lichtenberg; 🇩🇪 Berlin, Germany

CHU Cochin; 🇫🇷 Paris, France

Kreisklinik Biberach; 🇩🇪 Biberach, Germany

Hospital Universitarion Gregorio Maranon; 🇪🇸 Madrid, Spain