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

March 21, 2014 updated by: Laboratoires Mayoly Spindler

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France
        • Hôpital Avicenne
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Lyon, France
        • Hôpital Edouard Herriot
      • Montfermeil, France
        • Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
      • Nantes, France
        • CHU Hôtel Dieu
      • Nice, France
        • Hôpital l'Archet
      • Paris, France
        • CHU Cochin
      • Toulouse, France
        • Clinique Saint-Jean Languedoc
  • Germany
      • Berlin, Germany
        • Sana Klinikum Lichtenberg
      • Biberach, Germany
        • Kreisklinik Biberach
      • Heidenheim, Germany
        • Klinikum Heidenheim
      • Munchen, Germany
        • Medizinische Klinik und Poliklinik II Munchen
  • Spain
      • A Coruna, Spain
        • Complejo Hospitalario de A Coruña
      • Barcelona, Spain
        • Hospital Clínic de Barcelona
      • Fuenlabrada, Spain
        • Hospital De Fuenlabrada
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Madrid, Spain
        • Hospital Universitarion Gregorio Maranon
      • Pamplona, Spain
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: polyethylene glycol
4 Liters of PEG administered split in 2 doses
Drug: polyethylene glycol
Experimental: oral sodium phosphate tablets
oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid
Drug: oral sodium phosphate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall quality of bowel cleansing
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Mayoly Spindler

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ICOL121
  • 2012-005115-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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