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

Primary Purpose

Colonic Diseases, Intestinal Disease, Gastrointestinal Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PBK-1701TC
Standard oral preparation
Sponsored by
Pharmbio Korea Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Diseases focused on measuring Colonoscopy, PBK-1701TC, Bowel cleansing

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Chonnam National University Hospital
  • Kangbuk Samsung Hospital
  • Korea University Guro Hospital
  • Kyunghee University Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PBK-1701TC

Standard oral preparation

Arm Description

2-Day Split-Dosing Regimen

2-Day Split-Dosing Regimen

Outcomes

Primary Outcome Measures

Successful cleansing rate
%Patient with HCS-graded A or B

Secondary Outcome Measures

Overall cleansing rate
%Patient with each HCS-grade (A, B, C, D)
Mean segmental cleansing score
Mean HCS-grade in each segment (5 Segments: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum)
Mean cecal intubation time
Mean colonoscopy withdrawal time
Treatment compliance
%Patient who have completed taking the investigational products
Patient satisfaction
Patient questionnaire about any patient discomfort related to investigational products
Polyp detection rate

Full Information

First Posted
April 11, 2018
Last Updated
November 23, 2018
Sponsor
Pharmbio Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03509220
Brief Title
Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy
Official Title
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK-1701TC
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmbio Korea Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease
Keywords
Colonoscopy, PBK-1701TC, Bowel cleansing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PBK-1701TC
Arm Type
Experimental
Arm Description
2-Day Split-Dosing Regimen
Arm Title
Standard oral preparation
Arm Type
Active Comparator
Arm Description
2-Day Split-Dosing Regimen
Intervention Type
Drug
Intervention Name(s)
PBK-1701TC
Intervention Description
The subject will receive PBK-1701TC for colonoscopy.
Intervention Type
Drug
Intervention Name(s)
Standard oral preparation
Intervention Description
The subject will receive the standard oral preparation for colonoscopy
Primary Outcome Measure Information:
Title
Successful cleansing rate
Description
%Patient with HCS-graded A or B
Time Frame
Two days (from day of first dosing to day of colonoscopy)
Secondary Outcome Measure Information:
Title
Overall cleansing rate
Description
%Patient with each HCS-grade (A, B, C, D)
Time Frame
Two days (from day of first dosing to day of colonoscopy)
Title
Mean segmental cleansing score
Description
Mean HCS-grade in each segment (5 Segments: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum)
Time Frame
Two days (from day of first dosing to day of colonoscopy)
Title
Mean cecal intubation time
Time Frame
Two days (from day of first dosing to day of colonoscopy)
Title
Mean colonoscopy withdrawal time
Time Frame
Two days (from day of first dosing to day of colonoscopy)
Title
Treatment compliance
Description
%Patient who have completed taking the investigational products
Time Frame
Two days (from day of first dosing to day of colonoscopy)
Title
Patient satisfaction
Description
Patient questionnaire about any patient discomfort related to investigational products
Time Frame
Two days (from day of first dosing to day of colonoscopy)
Title
Polyp detection rate
Time Frame
Two days (from day of first dosing to day of colonoscopy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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