Clinical trial NCT03509220: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonic Diseases
Intestinal Disease
Gastrointestinal Disease
Digestive System Disease
Keywords: Colonoscopy
PBK-1701TC
Bowel cleansing
Lead sponsor: Pharmbio Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 235
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Successful cleansing rate
timeFrame: Two days (from day of first dosing to day of colonoscopy)
Secondary outcomes:
measure: Overall cleansing rate
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Mean segmental cleansing score
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Mean cecal intubation time
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Mean colonoscopy withdrawal time
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Treatment compliance
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Patient satisfaction
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Polyp detection rate
timeFrame: Two days (from day of first dosing to day of colonoscopy)
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: