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Completed

NCT Number: NCT01745835

Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation

comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation.

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Key information

Conditions

Healthy Person Bowel Preparation Before Colonoscopy

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, City, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • willing to consent/undergo necessary procedures
  • between the age of 20 and 75 years
  • healthy persons planning to have a colonoscopy

Exclusion criteria

  • history of abdominal surgery except appendectomy
  • inflammatory bowel disease
  • clinically or laboratory-confirmed ileus (both functional and mechanical)
  • malignancy
  • clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease
  • dementia, cognitive impairment
  • the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
  • known sensitivity to the agents used
  • Pregnancy, Lactating woman

Treatment and study plan

2L Coolprep®

Drug
  • Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Other names: 2L Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea)

1L Coolprep® and Bisacodyl

Drug
  • Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea)
  • Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
  • Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) * composition /1 tablet : Bisacodyl 5mg, docusate sodium 16.75mg

Other names: 1. Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 1L, 2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) : 4 tablet

Primary outcomes

  1. Bowel cleansing scale

    Time frame: on the day of the colonoscopy

    using SNUH scale

Secondary outcomes

  1. Bowel cleansing scale of Right/Transverse/Left colon

    Time frame: on the day of the colonoscopy

    also using SNUH scale

Other outcomes

  1. Patient's compliance

    Time frame: on the day of the colonoscopy

    using questionnaires

  2. Patient's acceptance

    Time frame: on the day of the colonoscopy

    using questionnare

  3. Patient's satisfaction

    Time frame: on the day of the colonoscopy

    using questionnaires

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation for Colonoscopy

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 10, 2012
Registry last updated
Mar 9, 2018

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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