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

NCT ID: NCT03509220

Last Updated: 2018-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2018-10-31

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.

Conditions

Colonic Diseases; Intestinal Disease; Gastrointestinal Disease; Digestive System Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PBK-1701TC

2-Day Split-Dosing Regimen

Group Type: EXPERIMENTAL

PBK-1701TC

Intervention Type: DRUG

The subject will receive PBK-1701TC for colonoscopy.

Standard oral preparation

2-Day Split-Dosing Regimen

Group Type: ACTIVE_COMPARATOR

Standard oral preparation

Intervention Type: DRUG

The subject will receive the standard oral preparation for colonoscopy

Interventions

PBK-1701TC

The subject will receive PBK-1701TC for colonoscopy.

Intervention Type: DRUG

Standard oral preparation

The subject will receive the standard oral preparation for colonoscopy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pharmbio Korea Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chonnam National University Hospital

Gwangju, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Kyunghee University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PBK-1701TC_P3

Identifier Type: -

Identifier Source: org_study_id