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

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ClinicalTrials.gov Identifier: NCT01513096
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : April 3, 2012
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, MD, Inje University

Brief Summary:
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 or disease Intervention/treatment Phase
Colonoscopy Bowel Preparation Drug: itopride Phase 3

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  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial
Study Start Date : November 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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



Primary Outcome Measures :
  1. bowel cleaning quality according to Ottawa scale scores [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. procedure time and polyp detection rate [ Time Frame: 3 months ]
    cecal intubation time, polyp detection rate, degree of patient discomfort



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513096


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

Responsible Party: Eun Hee Seo, MD, Professor, Inje University
ClinicalTrials.gov Identifier: NCT01513096     History of Changes
Other Study ID Numbers: GI-201201
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: January 2012

Keywords provided by Eun Hee Seo, MD, Inje University:
colonoscopy
bowel preparation
PEG
Prokinetics