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

NCT03509220 | Completed Phase 3

• 1 other identifier: PBK-1701TC_P3
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Colonoscopy; PBK-1701TC; Bowel cleansing

Outcome Measures

Primary Outcomes (1)

• Successful cleansing rate

  %Patient with HCS-graded A or B

  Two days (from day of first dosing to day of colonoscopy)

Secondary Outcomes (7)

• Overall cleansing rate

  Two days (from day of first dosing to day of colonoscopy)

• Mean segmental cleansing score

  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

  Two days (from day of first dosing to day of colonoscopy)

Study Arms (2)

PBK-1701TC

EXPERIMENTAL

2-Day Split-Dosing Regimen

Drug: PBK-1701TC

Standard oral preparation

ACTIVE COMPARATOR

2-Day Split-Dosing Regimen

Drug: Standard oral preparation

Interventions

PBK-1701TC DRUG

The subject will receive PBK-1701TC for colonoscopy.

PBK-1701TC

Standard oral preparation DRUG

The subject will receive the standard oral preparation for colonoscopy

Standard oral preparation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who is informed and give a consent in voluntary
• Patients who is scheduled a colonoscopy
• BMI 19≤and\<30

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmbio Korea Co., Ltd.: lead

Study Sites (5)

Chonnam National University Hospital

Gwangju, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyunghee University Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

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

Interventions

pbk-1701TC

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 26, 2018
• Study Start: April 11, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

KR (5)