MedTrace Logo

Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined

NCT03965182 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-05-28

No results posted yet for this study

Summary

Sodium picosulfate/magnesium citrate (SPMC) is generally better tolerated than PEG, its cleansing effect remains uncertain. While most studies showed SPMC was non-inferior to PEG, some studies reported that SPMC was less effective than PEG. To improve the bowel cleansing effect of SPMC, splitting the dose by using one sachet the evening before colonoscopy and the other sachet 4 to 5 hours before colonoscopy in the morning, has been proposed.Adding bisacodyl to the regimen also has been shown to be helpful. Some side effects, such as hyponatremia, dehydration and sleep disturbance, were reported to be more commonly associated with SPMC than with PEG.

To enhance the efficacy and reduce the side effects, two studies have evaluated the combination of SPMC and PEG, with conflicting results.The effect of combining PEG and SPMC should be best appreciated with head-to-head comparison with PEG and SPMC alone at the same time.

Therefore we designed this head-to-head comparison study for 2 L PEG, 1L PEG plus one sachet of SPMC and 2 sachet of SPMC, all with split-dose and the addition of 10 ml bisacodyl. Our hypothesis is the bowel cleansing effect of the combination regimen was not inferior to PEG alone. The tolerability, acceptability and side effects of the 3 regimen will also be evaluated.

Patients will be randomly assigned to either PEG, PEG plus SPMC or SPMC group, in a 1:1:1 ratio using a computer-generated sequence. The treatment allocation will be concealed and revealed by non-research medical personnel at the screening visit.

Conditions

  • Bowel Preparation

Interventions

DRUG

PEG

2 sachets of PEG will be used as the bowel prep regimen.

DRUG

PEG plus SPMC

one sachet of PEG and one sachet will be administered as the bowel prep regimen

DRUG

SPMC

2 sachets will be administered as the bowel prep regimen.

Sponsors & Collaborators

  • Dalin Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Yu-Hsi Hsieh, MD · Buddhist Dalin Tzu Chi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-05-31
Completion
2020-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03965182 on ClinicalTrials.gov