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

NCT ID: NCT01745835

Last Updated: 2018-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Person Bowel Preparation Before Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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2L Coolprep®

Group Type ACTIVE_COMPARATOR

2L Coolprep®

Intervention Type 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

1L Coolprep® and Bisacodyl

Group Type EXPERIMENTAL

1L Coolprep® and Bisacodyl

Intervention Type DRUG

1. 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
2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) \* composition /1 tablet : Bisacodyl 5mg, docusate sodium 16.75mg

Interventions

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2L Coolprep®

\* 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

Intervention Type DRUG

1L Coolprep® and Bisacodyl

1. 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
2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) \* composition /1 tablet : Bisacodyl 5mg, docusate sodium 16.75mg

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jong Pil Im, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, City, South Korea

Site Status

Countries

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South Korea

References

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Kwon JE, Lee JW, Im JP, Kim JW, Kim SH, Koh SJ, Kim BG, Lee KL, Kim SG, Kim JS, Jung HC. Comparable Efficacy of a 1-L PEG and Ascorbic Acid Solution Administered with Bisacodyl versus a 2-L PEG and Ascorbic Acid Solution for Colonoscopy Preparation: A Prospective, Randomized and Investigator-Blinded Trial. PLoS One. 2016 Sep 2;11(9):e0162051. doi: 10.1371/journal.pone.0162051. eCollection 2016.

Reference Type DERIVED
PMID: 27588943 (View on PubMed)

Other Identifiers

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Coolprep study

Identifier Type: -

Identifier Source: org_study_id

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