HealthyPhase 3NCT02551198
Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation
A Phase 3 study testing HAPREP® and SUCLEAR® in people with Healthy, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation. For bowel preparation, effective, well-tolerated and safe methods should be applied. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HAPREP® and SUCLEAR®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2015to 1 Sep 2017
- 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
- Age, between 20 and 75
- Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy
Who cannot join
- Gastrointestinal obstruction
- Bowel perforation
- Gastric retention
- Ileus
- Toxic colitis or toxic megacolon
- Known allergies to components of the OSS and PEG-Asc
Show all 14Show fewer
- History of colorectal resection
- History of abdominopelvic surgery within 6 months
- uncontrolled electrolyte imbalance
- hereditary Phenylketonuria
- Severe dehydration status
- seizure
- coma
- Glucose-6-phosphate dehydrogenase deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)
Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.
For bowel preparation, effective, well-tolerated and safe methods should be applied.
Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation
Read the detailed description
For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation
- Conditions
- Healthy
- Being tested
- HAPREP®, SUCLEAR®
- Keywords
- polyethylene glycol with ascorbic acid, oral sulfate solution, bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPREP®Drug
Also called 2L polyethylene glycol with ascorbic acidl PEG-Asc
Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc)
: : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]
SUCLEAR®Drug
Also called oral sulfate solution; OSS,
Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]
| Study group | Role | What they receive |
|---|---|---|
| HAPREP® (PEG-Asc) | Active comparator | subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation
: PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy] Receives: Drug: HAPREP® |
| SUCLEAR® (OSS) | Experimental | subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation
: OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy] Receives: Drug: SUCLEAR® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of bowel preparation
Measured: on the day of colonoscopy
Secondary outcomes (4)
5-point scale symptom questionnaire for drug tolerability
4(distressing) or 5(severely distressing) point would be untolerable
Measured: on the day of colonoscopy
Number of Participants with Adverse Events
Measured: on the day of colonoscopy
colonoscopy insertion time
Measured: on the day of colonoscopy
adenoma detection rate
Measured: whithin 3 weeks from the day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start1 Nov 2015
- Primary completion1 Mar 2016
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Daehang Hospital
- Responsible party
- Principal investigator, Dae Kyung Sohn, National Cancer Center, Korea
- Investigators
- Dae Kyung Sohn, M.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551198
- Sponsor's protocol ID
- NCC2015-0210
- Status last verified
- Jan 2019
- First submitted
- 11 Sep 2015
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT02551198
- Acronym / sponsor ID
- NCC2015-0210
- Conditions
- Healthy
- Keywords
- polyethylene glycol with ascorbic acid, oral sulfate solution, bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Daehang Hospital
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 16 Sep 2015 (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.
Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.
For bowel preparation, effective, well-tolerated and safe methods should be applied.
Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation
Detailed description
For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAPREP® (PEG-Asc) | Active comparator | Drug: HAPREP®subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy] |
| SUCLEAR® (OSS) | Experimental | Drug: SUCLEAR®subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation : OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy] |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age, between 20 and 75
- Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy
Key exclusion criteria (14 listed)
- Gastrointestinal obstruction
- Bowel perforation
- Gastric retention
- Ileus
- Toxic colitis or toxic megacolon
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 |
|---|---|---|
| HAPREP®Also: 2L polyethylene glycol with ascorbic acidl PEG-AscArm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc) : : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy] | Drug | HAPREP® (PEG-Asc) |
| SUCLEAR®Also: oral sulfate solution; OSS,Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy] | Drug | SUCLEAR® (OSS) |
Primary outcome
Adequacy of bowel preparation
Time frame: on the day of colonoscopy
4 secondary outcomes
5-point scale symptom questionnaire for drug tolerability
Time frame: on the day of colonoscopy
Number of Participants with Adverse Events
Time frame: on the day of colonoscopy
colonoscopy insertion time
Time frame: on the day of colonoscopy
adenoma detection rate
Time frame: whithin 3 weeks from the day of 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 17 Jan 2019.
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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.
Dae Kyung Sohn, M.D. principal investigator
National Cancer Center
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 HAPREP® and SUCLEAR® in people with Healthy, run by National Cancer Center, Korea 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 2 inclusion and 14 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 17 Jan 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.
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?
Adequacy of bowel preparation (time frame: on the day of colonoscopy). 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 17 Jan 2019.