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

Bowel Preparation Before Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745835
• Other study ID #: Coolprep study
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2012
• Last updated: March 7, 2018
• Start date: January 30, 2013
• Est. completion date: January 31, 2014

Study information

• Verified date: February 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: January 31, 2014
• Est. primary completion date: August 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation Before Colonoscopy
• Healthy Person

Intervention

Drug:
• 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
• 1L Coolprep® and Bisacodyl
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	City

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's compliance	using questionnaires	on the day of the colonoscopy
Other	Patient's acceptance	using questionnare	on the day of the colonoscopy
Other	Patient's satisfaction	using questionnaires	on the day of the colonoscopy
Primary	Bowel cleansing scale	using SNUH scale	on the day of the colonoscopy
Secondary	Bowel cleansing scale of Right/Transverse/Left colon	also using SNUH scale	on the day of the colonoscopy