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

• ClinicalTrials.gov Identifier: NCT03509220
• Recruitment Status: Completed
• First Posted: April 26, 2018
• Last Update Posted: November 26, 2018
• Sponsor: Pharmbio Korea Co., Ltd.
• Information provided by (Responsible Party): Pharmbio Korea Co., Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Colonic Diseases; Intestinal Disease; Gastrointestinal Disease; Digestive System Disease	Drug: PBK-1701TC; Drug: Standard oral preparation	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 235 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK-1701TC
• Actual Study Start Date: April 11, 2018
• Actual Primary Completion Date: October 31, 2018
• Actual Study Completion Date: October 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: PBK-1701TC; 2-Day Split-Dosing Regimen	Drug: PBK-1701TC; The subject will receive PBK-1701TC for colonoscopy.
Active Comparator: Standard oral preparation; 2-Day Split-Dosing Regimen	Drug: Standard oral preparation; The subject will receive the standard oral preparation for colonoscopy

Outcome Measures

Primary Outcome Measures :

1. Successful cleansing rate [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]
   %Patient with HCS-graded A or B

Secondary Outcome Measures :

1. Overall cleansing rate [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]
   %Patient with each HCS-grade (A, B, C, D)
2. Mean segmental cleansing score [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]
   Mean HCS-grade in each segment (5 Segments: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum)
3. Mean cecal intubation time [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]
4. Mean colonoscopy withdrawal time [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]
5. Treatment compliance [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]
   %Patient who have completed taking the investigational products
6. Patient satisfaction [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]
   Patient questionnaire about any patient discomfort related to investigational products
7. Polyp detection rate [ Time Frame: Two days (from day of first dosing to day of colonoscopy) ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

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, Korea, Republic of

Sponsors and Collaborators

Pharmbio Korea Co., Ltd.

More Information

• Responsible Party: Pharmbio Korea Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03509220
• Other Study ID Numbers: PBK-1701TC_P3
• First Posted: April 26, 2018
• Last Update Posted: November 26, 2018
• Last Verified: November 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pharmbio Korea Co., Ltd.:

Colonoscopy; PBK-1701TC; Bowel cleansing

Additional relevant MeSH terms:

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