Gastrointestinal Disease Clinical Trial
Official title:
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
NCT number | NCT05923918 |
Other study ID # | PBK_M2101_301 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 2023 |
Est. completion date | June 2024 |
This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.
Status | Recruiting |
Enrollment | 246 |
Est. completion date | June 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pharmbio Korea Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful cleansing rate | %Patient with HCS-graded A or B | From day of first dosing to day of colonoscopy | |
Secondary | Overall cleansing rate | %Patient with each HCS-grade (A, B, C, D) | From day of first dosing to day of colonoscopy | |
Secondary | Mean segmental cleansing score | 5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum. | From day of first dosing to day of colonoscopy | |
Secondary | Mean cecal intubation time | From day of first dosing to day of colonoscopy | ||
Secondary | Mean colonoscopy withdrawal time | From day of first dosing to day of colonoscopy | ||
Secondary | Treatment compliance | Dosage taken/Dosage scheduled | From day of first dosing to day of colonoscopy | |
Secondary | Patient satisfaction | Subject questionnaire (Taste, Difficulty, Ease of taking) | From day of first dosing to day of colonoscopy | |
Secondary | Polyp detection rate | From day of first dosing to day of colonoscopy |
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