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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01745835

Enrollment

196

Registered

2012-12-10

Start date

2013-01-30

Completion date

2014-01-31

Last updated

2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation Before Colonoscopy, Healthy Person

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.

Interventions

DRUG2L 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

DRUG1L 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bowel cleansing scale	on the day of the colonoscopy	using SNUH scale

Secondary

Measure	Time frame	Description
Bowel cleansing scale of Right/Transverse/Left colon	on the day of the colonoscopy	also using SNUH scale

Other

Measure	Time frame	Description
Patient's compliance	on the day of the colonoscopy	using questionnaires
Patient's acceptance	on the day of the colonoscopy	using questionnare
Patient's satisfaction	on the day of the colonoscopy	using questionnaires

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026