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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, MD, Inje University
ClinicalTrials.gov Identifier:
NCT01513096
First received: January 16, 2012
Last updated: March 30, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Bowel Preparation
 Drug: itopride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • bowel cleaning quality according to Ottawa scale scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • procedure time and polyp detection rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    cecal intubation time, polyp detection rate, degree of patient discomfort


Enrollment: 152
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513096

Locations
Korea, Republic of
Haeundae Paik Hospital, Inje University School of Medicine
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
  More Information

No publications provided

Responsible Party: Eun Hee Seo, MD, Professor, Inje University
ClinicalTrials.gov Identifier: NCT01513096     History of Changes
Other Study ID Numbers: GI-201201
Study First Received: January 16, 2012
Last Updated: March 30, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
colonoscopy
bowel preparation
PEG
Prokinetics

ClinicalTrials.gov processed this record on May 16, 2013