Intestinal DiseasePhase 3NCT05923918
A Study to Evaluate Safety and Efficacy of PBK_M2101
A Phase 3 study testing PBK_M2101 2-Day, PBK_M2101 1-Day and Oral Sulfate Tablet 2-Day in people with Intestinal Disease and Colonic Diseases, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
Trial summary
This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Disease, Colonic Diseases, Gastrointestinal Disease
- What is being tested?
- PBK_M2101 2-Day, PBK_M2101 1-Day and Oral Sulfate Tablet 2-Day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2023to Jun 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who is informed and give a consent in voluntary
- Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
- BMI 19≤and<30
Who cannot join
- Patients who participate in other interventional study or had participated within 30 days before screening
- Pregnant or breast-feeding women who do not want to stop breast-feeding
- Uncontrolled hypertension
- Uncontrolled diabetes
- Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
- HIV infection and/or chronic hepatitis B or C
- Patients who has a difficulty to participate because of severe nausea or vomiting
- History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul Asan Medical Center
Seoul
Byeon
About this study
Official title: A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.
- Being tested
- PBK_M2101 2-Day, PBK_M2101 1-Day, Oral Sulfate Tablet 2-Day
- Medical subject headings
- Intestinal Diseases, Colonic Diseases, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBK_M2101 2-DayDrug
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
PBK_M2101 1-DayDrug
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Oral Sulfate Tablet 2-DayDrug
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.
| Study group | Role | What they receive |
|---|---|---|
| test 1 | Experimental | PBK_M2101, 2-Day Regimen Receives: Drug: PBK_M2101 2-Day |
| test 2 | Experimental | PBK_M2101, 1-Day Regimen Receives: Drug: PBK_M2101 1-Day |
| active Comparator | Active comparator | active Comparator, 2-Day Regimen Receives: Drug: Oral Sulfate Tablet 2-Day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful cleansing rate
%Patient with HCS-graded A or B
Measured: From day of first dosing to day of colonoscopy
Secondary outcomes (7)
Overall cleansing rate
%Patient with each HCS-grade (A, B, C, D)
Measured: From day of first dosing to day of colonoscopy
Mean segmental cleansing score
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Measured: From day of first dosing to day of colonoscopy
Mean cecal intubation time
Measured: From day of first dosing to day of colonoscopy
Mean colonoscopy withdrawal time
Measured: From day of first dosing to day of colonoscopy
Treatment compliance
Dosage taken/Dosage scheduled
Measured: From day of first dosing to day of colonoscopy
Patient satisfaction
Subject questionnaire (Taste, Difficulty, Ease of taking)
Measured: From day of first dosing to day of colonoscopy
Polyp detection rate
Measured: 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 posted28 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byeon, M.D., Principal investigator, Seoul Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923918
- Sponsor's protocol ID
- PBK_M2101_301
- Status last verified
- Jun 2023
- First submitted
- 18 May 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
- ClinicalTrials.gov ID
- NCT05923918
- Acronym / sponsor ID
- PBK_M2101_301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 28 Jun 2023 (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 clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test 1 | Experimental | Drug: PBK_M2101 2-DayPBK_M2101, 2-Day Regimen |
| test 2 | Experimental | Drug: PBK_M2101 1-DayPBK_M2101, 1-Day Regimen |
| active Comparator | Active comparator | Drug: Oral Sulfate Tablet 2-Dayactive Comparator, 2-Day Regimen |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who is informed and give a consent in voluntary
- Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
- BMI 19≤and<30
Key exclusion criteria (8 listed)
- Patients who participate in other interventional study or had participated within 30 days before screening
- Pregnant or breast-feeding women who do not want to stop breast-feeding
- Uncontrolled hypertension
- Uncontrolled diabetes
- Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
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 |
|---|---|---|
| PBK_M2101 2-DaySubjects who are randomized into group test 1 will receive bowel preparation from evening to next morning. | Drug | test 1 |
| PBK_M2101 1-DaySubjects who are randomized into group test 2 will receive bowel preparation on the same-day. | Drug | test 2 |
| Oral Sulfate Tablet 2-DaySubjects who are randomized into group active comparative will receive bowel preparation from evening to next morning. | Drug | active Comparator |
Primary outcome
Successful cleansing rate
Time frame: From day of first dosing to day of colonoscopy
%Patient with HCS-graded A or B
7 secondary outcomes
Overall cleansing rate
Time frame: From day of first dosing to day of colonoscopy
Mean segmental cleansing score
Time frame: From day of first dosing to day of colonoscopy
Mean cecal intubation time
Time frame: From day of first dosing to day of colonoscopy
Mean colonoscopy withdrawal time
Time frame: From day of first dosing to day of colonoscopy
Treatment compliance
Time frame: From day of first dosing to day of colonoscopy
Patient satisfaction
Time frame: From day of first dosing to day of colonoscopy
Polyp detection rate
Time frame: 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 28 Jun 2023.
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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.
Byeon, M.D. principal investigator
Seoul Asan Medical 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 PBK_M2101 2-Day, PBK_M2101 1-Day and Oral Sulfate Tablet 2-Day in people with Intestinal Disease and Colonic Diseases, run by Pharmbio Korea Co., Ltd. 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 8 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 28 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manager Clinical Trial team, Pharmbio Korea (+82-2-587-2551, cr@pharmbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful cleansing rate (time frame: From day of first dosing to 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 28 Jun 2023.