Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy

Phase 3

Completed

• Conditions: Colonic Diseases; Intestinal Disease; Digestive System Disease; Gastrointestinal Disease
• Interventions: Drug: PBK-1701TC; Drug: Standard oral preparation

• Registration Number: NCT03509220
• Lead Sponsor: Pharmbio Korea Co., Ltd.

Brief Summary

This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing before colonoscopy. Half the participants will receive PBK-1701TC and while the other will receive standard oral preparation.

Detailed Description

This study is a prospective, randomized, single-blinded, parallel, 2-treatment, multi-center clinical trial. A total of 224 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-26
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-23
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

• Patients who is informed and give a consent in voluntary
• Patients who is scheduled a 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
• Women of childbearing potential who do not agree with appropriate contraception during this study
• Patients who had experienced any hypersensitivity study drug or ingredient
• Uncontrolled hypertension
• Arrhythmia with clinically significant findings from EKG
• Congestive heart failure; NYHA functional class III or IV; unstable coronary artery disease; myocardiac infarction history within 6 months
• Uncontrolled diabetes
• Active infection except acute upper respiratory infection or local skin infection; Fever (38 °C and higher) within 1 week before study administration
• HIV infection and/or chronic hepatitis B or C
• Patients who has a difficulty to participate because of severe nausea or vomiting
• Suspected or confirmed inflammatory bowel disease, toxic colon or toxic megacolon, or gastrointestinal obstruction or perforation; visible bleeding in colon
• History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
• Colonoscopy for the following use: treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g.,electrocoagulation, heater probe, laser or injection therapy); foreign body removal; decompression of acute nontoxic megacolon or sigmoid volvulus; balloon dilation of stenotic lesions (e.g., anastomotic strictures); palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting)
• Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
• Severe dehydration risk (e.g., rhabdomyolysis, ascites)
• History of hypersensitivity of drug or others
• Alcohol or drug abuse within 6 months
• Clinically significant underlying disease or medical history at investigator's discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBK-1701TC	PBK-1701TC	2-Day Split-Dosing Regimen
Standard oral preparation	Standard oral preparation	2-Day Split-Dosing Regimen

Primary Outcome Measures

Name	Time	Method
Successful cleansing rate	Two days (from day of first dosing to day of colonoscopy)	%Patient with HCS-graded A or B

Secondary Outcome Measures

Name	Time	Method
Mean cecal intubation time	Two days (from day of first dosing to day of colonoscopy)
Mean colonoscopy withdrawal time	Two days (from day of first dosing to day of colonoscopy)
Overall cleansing rate	Two days (from day of first dosing to day of colonoscopy)	%Patient with each HCS-grade (A, B, C, D)
Mean segmental cleansing score	Two days (from day of first dosing to day of colonoscopy)	Mean HCS-grade in each segment (5 Segments: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum)
Treatment compliance	Two days (from day of first dosing to day of colonoscopy)	%Patient who have completed taking the investigational products
Patient satisfaction	Two days (from day of first dosing to day of colonoscopy)	Patient questionnaire about any patient discomfort related to investigational products
Polyp detection rate	Two days (from day of first dosing to day of colonoscopy)

Trial Locations

Locations (5)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyunghee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of