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

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ClinicalTrials.gov Identifier: NCT01840553
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colon Cleansing Drug: oral sodium phosphate tablets Drug: polyethylene glycol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014


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



Primary Outcome Measures :
  1. overall quality of bowel cleansing [ Time Frame: day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840553


Locations
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France
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
Germany
Sana Klinikum Lichtenberg
Berlin, Germany
Kreisklinik Biberach
Biberach, Germany
Klinikum Heidenheim
Heidenheim, Germany
Medizinische Klinik und Poliklinik II Munchen
Munchen, Germany
Spain
Complejo Hospitalario de A Coruna
A Coruna, 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
Sponsors and Collaborators
Laboratoires Mayoly Spindler

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01840553     History of Changes
Other Study ID Numbers: ICOL121
2012-005115-13 ( EudraCT Number )
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: November 2013