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OpenTrials
Completed

NCT Number: NCT01513096

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

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.

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Key information

Conditions

Colonoscopy Bowel Preparation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Haeundae Paik Hospital, Inje University School of Medicine

Busan, 612-030, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itopride

Drug

itopride, 10mg, twice per day, for 1 day

Primary outcomes

  1. bowel cleaning quality according to Ottawa scale scores

    Time frame: 3 months

Secondary outcomes

  1. procedure time and polyp detection rate

    Time frame: 3 months

    cecal intubation time, polyp detection rate, degree of patient discomfort

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Acronym: PSPEG

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2012
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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