Colonic DiseasePhase 4NCT05249335
Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly
A Phase 4 study testing OST and 2L-PEG/Asc in people with Colonic Disease and Intestinal Disease, run by Pharmbio Korea Co., Ltd..
Trial summary
This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Disease, Intestinal Disease
- What is being tested?
- OST and 2L-PEG/Asc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Feb 2024
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age over 70
- Patients who is scheduled a colonoscopy
- Patients who is informed and give a consent in voluntary
Who cannot join
- History of colectomy
- Patients over American Society of Anesthesiology class III
- Patients who has difficulty swallowing
- In the case of abnormal findings requiring treatment in the basic blood test
- Patients with uncontrollable chronic diseases
- Patients suspected of having Paralytic ileus or intestinal obstruction.
Show all 9Show fewer
- Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.)
- Patients who has a history of drug abuse and addiction
- Patients who for any reason, are deemed by the Investigator to be inappropriate for this study
Trial locations and contacts
No sites are listed yet.
Yoon Jinyeong contact
About this study
Official title: Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly: Multicenter, Prospective, Investigator Single-blinded, Randomized Study
This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.
Read the detailed description
This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.
- Conditions
- Colonic Disease, Intestinal Disease
- Being tested
- OST, 2L-PEG/Asc
- Keywords
- colonoscopy, orafang, bowel cleaning
- Medical subject headings
- Colonic Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSTDrug
The subject will receive Orafang for colonoscopy
2L-PEG/AscDrug
The subject will receive 2L-PEG/Asc for colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| OST | Experimental | 2 days split dosing regimen Receives: Drug: OST |
| 2L-PEG/Asc | Active comparator | 2 days split dosing regimen Receives: Drug: 2L-PEG/Asc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful cleaning rate1
%Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment
Measured: Two days (from day of first dosing to day of colonoscopy)
Successful cleaning rate2
%Patient with HCS-graded A or B
Measured: Two days (from day of first dosing to day of colonoscopy)
Secondary outcomes (1)
Treatment compliance
%Patient who have completed taking the investigational products
Measured: Two days (from day of first dosing to 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 posted21 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
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 Colonic DiseaseStudies 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
- Model description
- multicenter, prospective, investigator single-blinded, randomized study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cha Jaemyeong, M.D, Ph.D, Study chair, Kyung Hee University Hospital at GangdongGang Hoseok, M.D, Ph.D, Principal investigator, HALLYM UNIV. MEDICAL CENTERSeo Geomseok, M.D, Ph.D, Principal investigator, Wonkwang University HospitalJeong Yunho, M.D, Ph.D, Principal investigator, Soon Chun Hanyang University College of MedicineNa Suyeong, M.D, Ph.D, Principal investigator, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249335
- Sponsor's protocol ID
- unconfirmed yet
- Status last verified
- Dec 2021
- First submitted
- 3 Jan 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kang HS, Na SY, Yoon JY, Jung Y, Seo GS, Cha JM. Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study. J Gastroenterol. 2024 May;59(5):402-410. doi: 10.1007/s00535-024-02089-9. Epub 2024 Mar 16.
PubMed 38492010
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly: Multicenter, Prospective, Investigator Single-blinded, Randomized Study
- ClinicalTrials.gov ID
- NCT05249335
- Acronym / sponsor ID
- unconfirmed yet
- Conditions
- Colonic Disease, Intestinal Disease
- Keywords
- colonoscopy, orafang, bowel cleaning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 21 Feb 2022 (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.
This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.
Detailed description
This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- multicenter, prospective, investigator single-blinded, randomized study
| Arm | Type | Receives |
|---|---|---|
| OST | Experimental | Drug: OST2 days split dosing regimen |
| 2L-PEG/Asc | Active comparator | Drug: 2L-PEG/Asc2 days split dosing regimen |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age over 70
- Patients who is scheduled a colonoscopy
- Patients who is informed and give a consent in voluntary
Key exclusion criteria (9 listed)
- History of colectomy
- Patients over American Society of Anesthesiology class III
- Patients who has difficulty swallowing
- In the case of abnormal findings requiring treatment in the basic blood test
- Patients with uncontrollable chronic diseases
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 |
|---|---|---|
| OSTThe subject will receive Orafang for colonoscopy | Drug | OST |
| 2L-PEG/AscThe subject will receive 2L-PEG/Asc for colonoscopy | Drug | 2L-PEG/Asc |
Primary outcome
Successful cleaning rate1
Time frame: Two days (from day of first dosing to day of colonoscopy)
%Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment
Successful cleaning rate2
Time frame: Two days (from day of first dosing to day of colonoscopy)
%Patient with HCS-graded A or B
1 secondary outcome
Treatment compliance
Time frame: Two days (from day of first dosing to day of colonoscopy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Derived from this study: PubMed 38492010Kang HS, Na SY, Yoon JY, Jung Y, Seo GS, Cha JM. Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study. J Gastroenterol. 2024 May;59(5):402-410. doi: 10.1007/s00535-024-02089-9. Epub 2024 Mar 16.
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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.
Yoon Jinyeong contact
Cha Jaemyeong, M.D, Ph.D study chair
Kyung Hee University Hospital at Gangdong
Gang Hoseok, M.D, Ph.D principal investigator
HALLYM UNIV. MEDICAL CENTER
Seo Geomseok, M.D, Ph.D principal investigator
Wonkwang University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OST and 2L-PEG/Asc in people with Colonic Disease and Intestinal Disease, run by Pharmbio Korea Co., Ltd..
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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cha Jaemyeong, M.D, Ph.D (+82-2-440-6113, clicknox@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful cleaning rate1 (time frame: Two days (from day of first dosing to day of 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 NCT05249335, 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 21 Feb 2022.