Title

Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    1044
Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy
To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.
Study Started
Nov 12
2016
Primary Completion
May 29
2017
Study Completion
Aug 17
2017
Results Posted
Oct 28
2020
Last Update
Oct 28
2020

Drug Natrium picosulfate / Magnesium citrate

Drug Polyethylene glycol / Ascorbic acid

Drug Polyethylene Glycols

PEG1D Active Comparator

Polyethylene glycols single dose a day before colonoscopy

PEG2D Active Comparator

Polyethylene glycols split dose

SPMC1D Active Comparator

Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy

SPMC2D Active Comparator

Natrium picosulfate/ Magnesium citrate split dose

PEGA1D Active Comparator

Polyethylene glycol / Ascorbic acid single dose day before colonoscopy

PEGA2D Active Comparator

Polyethylene glycol / Ascorbic acid split dose

Criteria

Inclusion Criteria:

Subjects referred to diagnostic or therapeutic colonoscopy

Exclusion Criteria:

ileus
known or suspected bowel obstruction
active bowel inflammation
pregnancy
any presence of serious medical conditions
history of prior colonic or rectal surgery
inability to obtain valid data from subject

Summary

PEGA1D

PEGA2D

PEG1D

PEG2D

SPMC1D

SPMC2D

All Events

Event Type Organ System Event Term

Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)

Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)

PEG1D

PEG2D

SPMC1D

SPMC2D

PEGA1D

PEGA2D

Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)

Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)

PEG1D

PEG2D

SPMC1D

SPMC2D

PEGA1D

PEGA2D

Total

973
Participants

Age, Continuous

62.1
years (Mean)
Standard Deviation: 14.2

Ethnicity (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

PEG1D

PEG2D

SPMC1D

SPMC2D

PEGA1D

PEGA2D

Drop/Withdrawal Reasons

PEG1D

PEG2D

SPMC1D

SPMC2D

PEGA1D

PEGA2D