Intestinal DiseasePhase 3NCT07114406
A Study to Evaluate Safety and Efficacy of PBK_M2502
A Phase 3 study testing PBK_M2502 1-Day and PBK_M2502 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_M2502 1-Day and PBK_M2502 2-Day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2025to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu
Cha Jaemyung, Principal Investigator
About this study
Official title: A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2502
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_M2502 1-Day, PBK_M2502 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_M2502 1-DayDrug
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
PBK_M2502 2-DayDrug
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | PBK_M2502, 1-Day Regimen Receives: Drug: PBK_M2502 1-Day |
| active Comparator | Active comparator | PBK_M2502, 2-Day Regimen Receives: Drug: PBK_M2502 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: Day 1 (day of colonoscopy)
Secondary outcomes (7)
Overall cleansing rate
%Patient with each HCS-grade (A, B, C, D)
Measured: Day 1 (day of colonoscopy)
Mean segmental cleansing score
5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.
Measured: Day 1 (day of colonoscopy)
Mean cecal intubation time
Measured: Day 1 (day of colonoscopy)
Mean colonoscopy withdrawal time
Measured: Day 1 (day of colonoscopy)
Treatment compliance
Dosage taken/Dosage scheduled
Measured: Day 1 (day of colonoscopy)
Patient satisfaction
Subject questionnaire (Taste, Difficulty, Ease of taking)
Measured: Day 1 (day of colonoscopy)
Polyp detection rate
Measured: Day 1 (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 posted11 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114406
- Sponsor's protocol ID
- PBK_M2502_301
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. 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_M2502
- ClinicalTrials.gov ID
- NCT07114406
- Acronym / sponsor ID
- PBK_M2502_301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Aug 2025 (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
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: PBK_M2502 1-DayPBK_M2502, 1-Day Regimen |
| active Comparator | Active comparator | Drug: PBK_M2502 2-DayPBK_M2502, 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_M2502 1-DaySubjects who are randomized into group test 2 will receive bowel preparation on the same-day. | Drug | Experimental |
| PBK_M2502 2-DaySubjects who are randomized into group test 1 will receive bowel preparation from evening to next morning. | Drug | active Comparator |
Primary outcome
Successful cleansing rate
Time frame: Day 1 (day of colonoscopy)
%Patient with HCS-graded A or B
7 secondary outcomes
Overall cleansing rate
Time frame: Day 1 (day of colonoscopy)
Mean segmental cleansing score
Time frame: Day 1 (day of colonoscopy)
Mean cecal intubation time
Time frame: Day 1 (day of colonoscopy)
Mean colonoscopy withdrawal time
Time frame: Day 1 (day of colonoscopy)
Treatment compliance
Time frame: Day 1 (day of colonoscopy)
Patient satisfaction
Time frame: Day 1 (day of colonoscopy)
Polyp detection rate
Time frame: Day 1 (day of colonoscopy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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.
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_M2502 1-Day and PBK_M2502 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: opening soon, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: Day 1 (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 11 Aug 2025.