Healthy PersonPhase 3NCT01745835
Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation
A Phase 3 study testing 2L Coolprep® and 1L Coolprep® and Bisacodyl in people with Healthy Person and Bowel Preparation Before Colonoscopy, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Person, Bowel Preparation Before Colonoscopy
- What is being tested?
- 2L Coolprep® and 1L Coolprep® and Bisacodyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2013to 31 Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willing to consent/undergo necessary procedures
- between the age of 20 and 75 years
- healthy persons planning to have a colonoscopy
Who cannot join
- 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
Show all 9Show fewer
- the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
- known sensitivity to the agents used
- Pregnancy, Lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation for Colonoscopy
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.
- Being tested
- 2L Coolprep®, 1L Coolprep® and Bisacodyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2L Coolprep®Drug
Also called 2L 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
1L Coolprep® and BisacodylDrug
Also called 1. Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 1L, 2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) : 4 tablet
- 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
| Study group | Role | What they receive |
|---|---|---|
| 2L Coolprep® | Active comparator | Not described Receives: Drug: 2L Coolprep® |
| 1L Coolprep® and Bisacodyl | Experimental | Not described Receives: Drug: 1L Coolprep® and Bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleansing scale
using SNUH scale
Measured: on the day of the colonoscopy
Secondary outcomes (1)
Bowel cleansing scale of Right/Transverse/Left colon
also using SNUH scale
Measured: on the day of the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study start30 Jan 2013
- Primary completion31 Aug 2013
- Study completion31 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy PersonStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Pil Im, M.D.,Ph.D., Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745835
- Sponsor's protocol ID
- Coolprep study
- Status last verified
- Feb 2017
- First submitted
- 27 Nov 2012
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27588943
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT01745835
- Acronym / sponsor ID
- Coolprep study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 31 Aug 2013 (actual)
- Study completion
- 31 Jan 2014 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2L Coolprep® | Active comparator | Drug: 2L Coolprep® |
| 1L Coolprep® and Bisacodyl | Experimental | Drug: 1L Coolprep® and Bisacodyl |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- willing to consent/undergo necessary procedures
- between the age of 20 and 75 years
- healthy persons planning to have a colonoscopy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2L Coolprep®Also: 2L 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 | Drug | 2L Coolprep® |
| 1L Coolprep® and BisacodylAlso: 1. Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 1L, 2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) : 4 tablet1. 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 | Drug | 1L Coolprep® and Bisacodyl |
Primary outcome
Bowel cleansing scale
Time frame: on the day of the colonoscopy
using SNUH scale
1 secondary outcome
Bowel cleansing scale of Right/Transverse/Left colon
Time frame: on the day of the colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Derived from this study: PubMed 27588943Kwon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Pil Im, M.D.,Ph.D. study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2L Coolprep® and 1L Coolprep® and Bisacodyl in people with Healthy Person and Bowel Preparation Before Colonoscopy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel cleansing scale (time frame: on the day of the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.