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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2023
Source Pharmbio Korea Co., Ltd.
Contact Manager Clinical Trial team, Pharmbio Korea
Phone +82-2-587-2551
Email cr@pharmbio.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
PBK_M2101 2-Day
Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.
PBK_M2101 1-Day
Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.
Oral Sulfate Tablet 2-Day
Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.

Locations

Country Name City State
Korea, Republic of Seoul Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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