NCT02980562

Brief Summary

Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg) formulation to determine the quality of bowel cleansing and patient tolerability.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

November 30, 2016

Last Update Submit

December 1, 2016

Conditions

Bowel DiseaseColon Adenoma

Keywords

Bowel preparationAscorbic acidBisacodylPolyethylene glycol

Outcome Measures

Primary Outcomes (1)

  • The quality of the bowel preparation using preparation scale

    Preparation scale

    20 minutes

Secondary Outcomes (1)

  • The patient's tolerability

    30 minutes before the colonoscopy

Study Arms (2)

2L Polyethylene glycols-Asc

ACTIVE COMPARATOR

1 L of PEG containing ascorbic acid (PEG A) was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure. All colonoscopies were performed between 9 am and 1 pm.

Drug: Polyethylene Glycols

1L PEG-Asc plus bisacodyl

ACTIVE COMPARATOR

10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.

Drug: Bisacodyl

Interventions

Polyethylene GlycolsDRUG

(Split dose 2L PEG-Asc)

Also known as: Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea
2L Polyethylene glycols-Asc
BisacodylDRUG

(1L PEG-Asc plus bisacodyl)

Also known as: Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea, Dulcorax-S®; Boehringer Ingelheim, Seoul, Korea
1L PEG-Asc plus bisacodyl

Eligibility Criteria

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

You may qualify if:

  • All patients between the ages of 20 and 75 years who were scheduled to undergo colonoscopy

You may not qualify if:

  • aged more than 75 years.
  • known or suspected gastrointestinal obstruction, Ileus
  • severe heart failure
  • uncontrolled hypertension (systolic pressure \> 170 mmHg, diastolic pressure \> 100 mmHg)
  • severe constipation
  • clinically significant electrolyte abnormalities
  • any prior bowel resection, or significant gastroparesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kang SH, Jeen YT, Lee JH, Yoo IK, Lee JM, Kim SH, Choi HS, Kim ES, Keum B, Lee HS, Chun HJ, Kim CD. Comparison of a split-dose bowel preparation with 2 liters of polyethylene glycol plus ascorbic acid and 1 liter of polyethylene glycol plus ascorbic acid and bisacodyl before colonoscopy. Gastrointest Endosc. 2017 Aug;86(2):343-348. doi: 10.1016/j.gie.2016.10.040. Epub 2016 Nov 23.

    PMID: 27889546DERIVED

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Polyethylene GlycolsBisacodyl

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureCresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Yoon Tae Jeen

    Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine

    STUDY DIRECTOR

  • Seung Hun Kang

    Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

December 2, 2016

Record last verified: 2016-11