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

A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK-1701TC

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.

Study Overview

• Status: Completed
• Conditions: Colonic Diseases; Digestive System Disease; Gastrointestinal Disease; Intestinal Disease
• Intervention / Treatment: Drug: PBK-1701TC; Drug: 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 Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of
    • KyungHee University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBK-1701TC; 2-Day Split-Dosing Regimen	Drug: PBK-1701TC; The subject will receive PBK-1701TC for colonoscopy.
Active Comparator: Standard oral preparation; 2-Day Split-Dosing Regimen	Drug: Standard oral preparation; The subject will receive the standard oral preparation for colonoscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pharmbio Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Colonoscopy; PBK-1701TC; Bowel cleansing
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: PBK-1701TC_P3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No