Colon AdenomaPhase 4NCT04758156
Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy
A Phase 4 study testing CleanViewAL and SUPREP in people with Colon Adenoma and Colonic Polyp, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Adenoma, Colonic Polyp
- What is being tested?
- CleanViewAL and SUPREP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Phase 4
- 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
- Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care
Who cannot join
- previous history of significant gastrointestinal surgeries (except for appendectomy)
- known or clinically suspicious Inflammatory bowel disease patients
- known or suspected ileus/ GI obstruction
- previous history of major cancer or currently on treating cancer
- Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication
- severe cognitive impairment / dementia / confusion state
Show all 12Show fewer
- past history within the last 12 months or current episode of severe constipation severe constipation
- Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation)
- women who are pregnant or lactating
- known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency
- those who were allergic to any preparation components.
- those who, in the opinion of the investigator, should not be included in the study for any reason
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university hospital
Seoul, 03080
Hyun Jung Lee, MD, PhD, +82-2-740-3439, guswjd80@gmail.com
About this study
Official title: Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy: Prospective, Randomized, Parallel, Multi-center Trial
Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy
study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University )
patient inclusion criteria
- aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care
- Conditions
- Colon Adenoma, Colonic Polyp
- Being tested
- CleanViewAL, SUPREP
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanViewALDrug
1L PEG + ascorbic acid bowel preparation for colonoscopy
SUPREPDrug
Oral sulfate solution for colonoscopy bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| CleanViewAL | Experimental | 1L polyethylene glycol+ascorbic acid split dose Receives: Drug: CleanViewAL |
| SUPREP | Placebo comparator | Oral sulfate solutiom Receives: Drug: SUPREP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BBPS)
Bowel cleansing score
Measured: at the time of colonoscopy procedure
Secondary outcomes (1)
questionnaire gathered for Tolerability, compliance, satisfaction
information gathered via questionnaire
Measured: on the 1 day of colonoscopy via questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Aug 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jung Lee, Seoul National University Hospital
- Investigators
- Jong Pil Im, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758156
- Sponsor's protocol ID
- 1905-1831
- Status last verified
- Jul 2021
- First submitted
- 15 Feb 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy: Prospective, Randomized, Parallel, Multi-center Trial
- ClinicalTrials.gov ID
- NCT04758156
- Acronym / sponsor ID
- 1905-1831
- Conditions
- Colon Adenoma, Colonic Polyp
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Feb 2021 (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.
Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy
study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University )
patient inclusion criteria
- aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CleanViewAL | Experimental | Drug: CleanViewAL1L polyethylene glycol+ascorbic acid split dose |
| SUPREP | Placebo comparator | Drug: SUPREPOral sulfate solutiom |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care
Key exclusion criteria (12 listed)
- previous history of significant gastrointestinal surgeries (except for appendectomy)
- known or clinically suspicious Inflammatory bowel disease patients
- known or suspected ileus/ GI obstruction
- previous history of major cancer or currently on treating cancer
- Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication
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 |
|---|---|---|
| CleanViewAL1L PEG + ascorbic acid bowel preparation for colonoscopy | Drug | CleanViewAL |
| SUPREPOral sulfate solution for colonoscopy bowel preparation | Drug | SUPREP |
Primary outcome
Boston Bowel Preparation Scale (BBPS)
Time frame: at the time of colonoscopy procedure
Bowel cleansing score
1 secondary outcome
questionnaire gathered for Tolerability, compliance, satisfaction
Time frame: on the 1 day of colonoscopy via questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- 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.
Jong Pil Im, MD, PhD principal investigator
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 4 study testing CleanViewAL and SUPREP in people with Colon Adenoma and Colonic Polyp, 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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Jung Lee, MD, PhD (+82-2-740-3439, guswjd80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (BBPS) (time frame: at the time of colonoscopy procedure). 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 7 Jul 2021.