Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation (PSPEG)

March 30, 2012 updated by: Eun Hee Seo, MD, Inje University

Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial

In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.

Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure

Study Type

Interventional

Enrollment (Actual)

152

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-030
        • Haeundae Paik Hospital, Inje University School of Medicine

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient who are scheduled for colonoscopy

Exclusion Criteria:

  • pregnancy,
  • breast feeding,
  • known or suspected bowel obstruction, and
  • known allergy to PEG or Itopride ,
  • presence of severe illness(renal failure, congestive heart failure, liver failure,), and
  • refusal of consent to participate in the study

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Split-dose PEG
Bowel preparation using split dose PEG without prokinetics
Active Comparator: Split dose PEG with prokinetics
Bowel preparation using split-dose PEG with prokinetics
Drug: itopride
itopride, 10mg, twice per day, for 1 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bowel cleaning quality according to Ottawa scale scores
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure time and polyp detection rate
Time Frame: 3 months
cecal intubation time, polyp detection rate, degree of patient discomfort
3 months

Collaborators and Investigators

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

Sponsor

Inje University

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

November 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

April 3, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GI-201201

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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