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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colonic Diseases, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease

Intervention / Treatment
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* Drug: PBK-1701TC
* Drug: Standard oral preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, PBK-1701TC, Bowel cleansing