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Completed

NCT Number: NCT01840553

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

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.

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Key information

Conditions

Colon Cleansing

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Avicenne, Bobigny, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral sodium phosphate tablets

Drug

Polyethylene glycol

Drug

Primary outcomes

  1. overall quality of bowel cleansing

    Time frame: day 1

Sponsors and collaborators

Lead sponsor

Laboratoires Mayoly Spindler

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2013
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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