NCT01745835

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2014

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

November 27, 2012

Last Update Submit

March 7, 2018

Conditions

Healthy PersonBowel Preparation Before Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Bowel cleansing scale

    using SNUH scale

    on the day of the colonoscopy

Secondary Outcomes (1)

  • Bowel cleansing scale of Right/Transverse/Left colon

    on the day of the colonoscopy

Other Outcomes (3)

  • Patient's compliance

    on the day of the colonoscopy

  • Patient's acceptance

    on the day of the colonoscopy

  • Patient's satisfaction

    on the day of the colonoscopy

Study Arms (2)

2L Coolprep®

ACTIVE COMPARATOR
Drug: 2L Coolprep®

1L Coolprep® and Bisacodyl

EXPERIMENTAL
Drug: 1L Coolprep® and Bisacodyl

Interventions

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

Also known as: 2L Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea)
2L Coolprep®
1L Coolprep® and BisacodylDRUG

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

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

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, City, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27588943DERIVED

MeSH Terms

Interventions

Bisacodyl

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jong Pil Im, M.D.,Ph.D.

    Seoul National University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 10, 2012

Study Start

January 30, 2013

Primary Completion

August 31, 2013

Study Completion

January 31, 2014

Last Updated

March 9, 2018

Record last verified: 2017-02

Locations

KR(1)