Cathartic ColonPhase 4NCT02761213
Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid
A Phase 4 study testing Oral sulfate solution (OSS) and 2-L PEG/Asc in people with Cathartic Colon, run by Bo-In Lee at 1 site in South Korea.
Trial summary
The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cathartic Colon
- What is being tested?
- Oral sulfate solution (OSS) and 2-L PEG/Asc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Aug 2017
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- people who receive colonoscopy
- aged : 18-80
- people who sign the consent
Who cannot join
- those aged over 80 years
- the disabled
- intestinal obstruction
- severe constipation
- previous history of bowel resection
- liver cirrhosis
Show all 11Show fewer
- heart failure or ischemic heart disease within 6 months
- inflammatory bowel disease
- pregnant women
- severe renal insufficiency
- people who refuse to sign the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study
The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.
Read the detailed description
High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.
Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.
In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).
- Conditions
- Cathartic Colon
- Being tested
- Oral sulfate solution (OSS), 2-L PEG/Asc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sulfate solution (OSS)Drug
Also called SUPREP
Oral sulfate solution (OSS)
2-L PEG/AscDrug
Also called COOLPREP
Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.
| Study group | Role | What they receive |
|---|---|---|
| Oral sulfate solution (OSS) | Experimental | oral sulfate solution (OSS) Receives: Drug: Oral sulfate solution (OSS) |
| 2-L PEG/Asc | Active comparator | low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) Receives: Drug: 2-L PEG/Asc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BPPS)
Measured: during colonoscopy
Aronchick scale
Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon.
Measured: during colonoscopy
Secondary outcomes (7)
Tolerability by a patient questionnaire using 5-point Likert scale
to assess tolerability of each bowel preparation
Measured: on arrival at the endoscopy unit before colonoscopy
Safety by measuring hemodynamic and biochemical data
Biochemical data will be measured only in case of necessity such as weakness, mental change or numbness.
Measured: at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite
Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers
Measured: during colonoscopy
Percentage of cecal intubation
Measured: during colonoscopy
Insertion time
Measured: during colonoscopy
Withdrawal time
Measured: during colonoscopy
Adenoma detection rate
Measured: during colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cathartic ColonStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo-In Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmbio Korea Co., Ltd.
- Responsible party
- Sponsor-investigator, Bo-In Lee, Seoul St. Mary's Hospital
- Investigators
- Bo-In Lee, MD, PhD, Study director, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761213
- Sponsor's protocol ID
- KC16MISV0004
- Status last verified
- Oct 2017
- First submitted
- 22 Apr 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85. doi: 10.1111/j.1572-0241.2006.00673.x. No abstract available.
PubMed 16635231Bannas P, Bakke J, Patrick JL, Pickhardt PJ. Automated volumetric analysis for comparison of oral sulfate solution (SUPREP) with established cathartic agents at CT colonography. Abdom Imaging. 2015 Jan;40(1):11-8. doi: 10.1007/s00261-014-0186-x.
PubMed 24965898Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.
PubMed 25028274Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.
PubMed 30308546
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02761213
- Acronym / sponsor ID
- KC16MISV0004
- Conditions
- Cathartic Colon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bo-In LeeUniversity, hospital or other
- Collaborators
- Pharmbio Korea Co., Ltd.
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 May 2016 (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.
The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.
Detailed description
High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.
Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.
In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral sulfate solution (OSS) | Experimental | Drug: Oral sulfate solution (OSS)oral sulfate solution (OSS) |
| 2-L PEG/Asc | Active comparator | Drug: 2-L PEG/Asclow-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- people who receive colonoscopy
- aged : 18-80
- people who sign the consent
Key exclusion criteria (11 listed)
- those aged over 80 years
- the disabled
- intestinal obstruction
- severe constipation
- previous history of bowel resection
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 |
|---|---|---|
| Oral sulfate solution (OSS)Also: SUPREPOral sulfate solution (OSS) | Drug | Oral sulfate solution (OSS) |
| 2-L PEG/AscAlso: COOLPREPLow-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc. | Drug | 2-L PEG/Asc |
Primary outcome
Boston Bowel Preparation Scale (BPPS)
Time frame: during colonoscopy
Aronchick scale
Time frame: during colonoscopy
Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon.
7 secondary outcomes
Tolerability by a patient questionnaire using 5-point Likert scale
Time frame: on arrival at the endoscopy unit before colonoscopy
Safety by measuring hemodynamic and biochemical data
Time frame: at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite
Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers
Time frame: during colonoscopy
Percentage of cecal intubation
Time frame: during colonoscopy
Insertion time
Time frame: during colonoscopy
Withdrawal time
Time frame: during colonoscopy
Adenoma detection rate
Time frame: during 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 11 Oct 2017.
- Background: PubMed 16635231Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85. doi: 10.1111/j.1572-0241.2006.00673.x. No abstract available.
- Background: PubMed 24965898Bannas P, Bakke J, Patrick JL, Pickhardt PJ. Automated volumetric analysis for comparison of oral sulfate solution (SUPREP) with established cathartic agents at CT colonography. Abdom Imaging. 2015 Jan;40(1):11-8. doi: 10.1007/s00261-014-0186-x.
- Background: PubMed 25028274Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.
- Derived from this study: PubMed 30308546Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.
- Individual participant dataSharing planned: No
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.
Bo-In Lee, MD, PhD study director
Seoul St. Mary's 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 Oral sulfate solution (OSS) and 2-L PEG/Asc in people with Cathartic Colon, run by Bo-In Lee 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 11 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 11 Oct 2017. 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 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?
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 (BPPS) (time frame: during colonoscopy). The study lists 2 primary outcomes in all. 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 NCT02761213, which also lists 4 linked publications.
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 11 Oct 2017; AzTrials last refreshed its copy on 28 Oct 2026.