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

Pharmbio Korea

Status and phase

Completed

Phase 3

Conditions

Gastrointestinal Disease

Intestinal Disease

Colonic Diseases

Digestive System Disease

Treatments

Drug: PBK-1701TC

Drug: Standard oral preparation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03509220

PBK-1701TC_P3

Details and patient eligibility

About

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.

Full 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.

Enrollment

235 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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