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

Gastrointestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509220
• Other study ID #: PBK-1701TC_P3
• Status: Completed
• Phase: Phase 3
• Start date: April 11, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: November 2018
• Source: Pharmbio Korea Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• 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 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

Related Conditions & MeSH terms

• Colonic Diseases
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Intestinal Disease
• Intestinal Diseases

Intervention

Drug:
• PBK-1701TC
The subject will receive PBK-1701TC for colonoscopy.
• Standard oral preparation
The subject will receive the standard oral preparation for colonoscopy

Locations

Country	Name	City	State
Korea, Republic of	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

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	Two days (from day of first dosing to day of colonoscopy)
Secondary	Overall cleansing rate	%Patient with each HCS-grade (A, B, C, D)	Two days (from day of first dosing to day of colonoscopy)
Secondary	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)
Secondary	Mean cecal intubation time		Two days (from day of first dosing to day of colonoscopy)
Secondary	Mean colonoscopy withdrawal time		Two days (from day of first dosing to day of colonoscopy)
Secondary	Treatment compliance	%Patient who have completed taking the investigational products	Two days (from day of first dosing to day of colonoscopy)
Secondary	Patient satisfaction	Patient questionnaire about any patient discomfort related to investigational products	Two days (from day of first dosing to day of colonoscopy)
Secondary	Polyp detection rate		Two days (from day of first dosing to day of colonoscopy)