Evaluating the safety and effectiveness of PBK_M2101 for intestinal diseases
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
This study is testing a new treatment called PBK_M2101 to see if it is safe and effective for people with intestinal diseases compared to a standard oral medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Pharmbio Korea Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05923918 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a Phase 3, prospective, randomized, single-blind study designed to evaluate the safety and efficacy of PBK_M2101 in patients with intestinal diseases. It involves three treatment arms, including two different dosing regimens of PBK_M2101 and an active control using an oral sulfate tablet. The trial is conducted across multiple centers and aims to confirm the findings of earlier phases regarding the treatment's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for esophagogastroduodenoscopy and colonoscopy with a BMI between 19 and 30.
Not a fit: Patients with uncontrolled hypertension, diabetes, or those with significant gastrointestinal disturbances may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from various gastrointestinal diseases.
How similar studies have performed: Other studies have shown promise in treating gastrointestinal diseases with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who is informed and give a consent in voluntary * Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy * BMI 19≤and\<30 Exclusion Criteria: * 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
Where this trial is running
Seoul
- Seoul Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Byeon, M.D. — Seoul Asan Medical Center
- Study coordinator: Manager Clinical Trial team, Pharmbio Korea
- Email: cr@pharmbio.co.kr
- Phone: +82-2-587-2551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.