Bowel PreparationNCT03849196
Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG
A study testing 2L PEG-Asc, Bisacodyl 10Mg Suppository and 1L PEG-Asc in people with Bowel Preparation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- 2L PEG-Asc, Bisacodyl 10Mg Suppository and 1L PEG-Asc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2017to 30 Jan 2018
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- outpatients who were scheduled for colonoscopy between August 2017 and January 2018
Who cannot join
- History of gastrointestinal tract surgery
- History of inflammatory bowel disease
- History of severe active colitis
- History of chronic kidney disease
- pregnant woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simultaneous Combination of Bisacodyl Suppository Agent and 1L Polyethylene Glycol Plus Ascorbic Acid is Not Inferior and Comfortable Regimen Compared With 2L Polyethylene Glycol Plus Ascorbic Acid: A Randomized Controlled Study
Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.
Read the detailed description
Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018
Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.
Outcome measures: the Boston Bowel Preparation Scale (BBPS)
- Conditions
- Bowel Preparation
- Being tested
- 2L PEG-Asc, Bisacodyl 10Mg Suppository, 1L PEG-Asc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2L PEG-AscDrug
Also called clicool, coolprep
PEG-Asc powder
Bisacodyl 10Mg SuppositoryDrug
bisacodyl 10 mg suppository
1L PEG-AscDrug
Also called clicool, coolprep
PEG-Asc powder
| Study group | Role | What they receive |
|---|---|---|
| 2L PEG-Asc | Experimental | 2L PEG-Asc for bowel preparation Receives: Drug: 2L PEG-Asc |
| 1L PEG-Asc & 'Bisacodyl 10Mg Suppository | Active comparator | 1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation Receives: Drug: Bisacodyl 10Mg Suppository; Drug: 1L PEG-Asc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BBPS).
4-point scoring system (0-3) applied to each of the 3 colon segments (right colon including cecum and ascending colon, transverse colon including transverse colon, hepatic and splenic flexure, left colon including descending colon, sigmoid colon, and rectum)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start31 Jul 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, and observer-blind study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Ran Kim, Samsung Medical Center
- Investigators
- brian.biochem@gmail.com Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849196
- Sponsor's protocol ID
- 2017-05-100
- Status last verified
- Feb 2019
- First submitted
- 16 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Combination of Bisacodyl Suppository Agent and 1L Polyethylene Glycol Plus Ascorbic Acid is Not Inferior and Comfortable Regimen Compared With 2L Polyethylene Glycol Plus Ascorbic Acid: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03849196
- Acronym / sponsor ID
- 2017-05-100
- Conditions
- Bowel Preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 21 Feb 2019 (actual)
- 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.
Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.
Detailed description
Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018
Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.
Outcome measures: the Boston Bowel Preparation Scale (BBPS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, and observer-blind study
| Arm | Type | Receives |
|---|---|---|
| 2L PEG-Asc | Experimental | Drug: 2L PEG-Asc2L PEG-Asc for bowel preparation |
| 1L PEG-Asc & 'Bisacodyl 10Mg Suppository | Active comparator | Drug: Bisacodyl 10Mg Suppository, Drug: 1L PEG-Asc1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients who were scheduled for colonoscopy between August 2017 and January 2018
Key exclusion criteria (5 listed)
- History of gastrointestinal tract surgery
- History of inflammatory bowel disease
- History of severe active colitis
- History of chronic kidney disease
- pregnant woman.
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 PEG-AscAlso: clicool, coolprepPEG-Asc powder | Drug | 2L PEG-Asc |
| Bisacodyl 10Mg Suppositorybisacodyl 10 mg suppository | Drug | 1L PEG-Asc & 'Bisacodyl 10Mg Suppository |
| 1L PEG-AscAlso: clicool, coolprepPEG-Asc powder | Drug | 1L PEG-Asc & 'Bisacodyl 10Mg Suppository |
Primary outcome
Boston Bowel Preparation Scale (BBPS).
Time frame: 1 hour
4-point scoring system (0-3) applied to each of the 3 colon segments (right colon including cecum and ascending colon, transverse colon including transverse colon, hepatic and splenic flexure, left colon including descending colon, sigmoid colon, and rectum)
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 21 Feb 2019.
- Individual participant dataSharing planned: No
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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.
brian.biochem@gmail.com Kim principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2L PEG-Asc, Bisacodyl 10Mg Suppository and 1L PEG-Asc in people with Bowel Preparation, run by Samsung Medical Center 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 1 inclusion and 5 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 21 Feb 2019. 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.
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?
Boston Bowel Preparation Scale (BBPS). (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2019.