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

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

Further study details as provided by Eun Hee Seo, MD, Inje University:

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

Secondary Outcome Measures:
  • procedure time and polyp detection rate [ Time Frame: 3 months ]
    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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01513096

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

Responsible Party: Eun Hee Seo, MD, Professor, Inje University Identifier: NCT01513096     History of Changes
Other Study ID Numbers: GI-201201
Study First Received: January 16, 2012
Last Updated: March 30, 2012

Keywords provided by Eun Hee Seo, MD, Inje University:
bowel preparation
Prokinetics processed this record on September 21, 2017