Colonic DiseasesPhase 3NCT03509220
Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy
A Phase 3 study testing PBK-1701TC and Standard oral preparation in people with Colonic Diseases and Intestinal Disease, run by Pharmbio Korea Co., Ltd. at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Diseases, Intestinal Disease, Gastrointestinal Disease
- What is being tested?
- PBK-1701TC and Standard oral preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 11 Apr 2018to 31 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who is informed and give a consent in voluntary
- Patients who is scheduled a colonoscopy
- BMI 19≤and<30
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Chonnam National University Hospital
Gwangju
Kangbuk Samsung Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyunghee University Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK-1701TC
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.
Read the 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.
- Being tested
- PBK-1701TC, Standard oral preparation
- Keywords
- Colonoscopy, PBK-1701TC, Bowel cleansing
- Medical subject headings
- Colonic Diseases, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBK-1701TCDrug
The subject will receive PBK-1701TC for colonoscopy.
Standard oral preparationDrug
The subject will receive the standard oral preparation for colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| PBK-1701TC | Experimental | 2-Day Split-Dosing Regimen Receives: Drug: PBK-1701TC |
| Standard oral preparation | Active comparator | 2-Day Split-Dosing Regimen Receives: Drug: Standard oral preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful cleansing rate
%Patient with HCS-graded A or B
Measured: Two days (from day of first dosing to day of colonoscopy)
Secondary outcomes (7)
Overall cleansing rate
%Patient with each HCS-grade (A, B, C, D)
Measured: 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)
Measured: Two days (from day of first dosing to day of colonoscopy)
Mean cecal intubation time
Measured: Two days (from day of first dosing to day of colonoscopy)
Mean colonoscopy withdrawal time
Measured: Two days (from day of first dosing to day of colonoscopy)
Treatment compliance
%Patient who have completed taking the investigational products
Measured: Two days (from day of first dosing to day of colonoscopy)
Patient satisfaction
Patient questionnaire about any patient discomfort related to investigational products
Measured: Two days (from day of first dosing to day of colonoscopy)
Polyp detection rate
Measured: Two days (from day of first dosing to day of colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start11 Apr 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509220
- Sponsor's protocol ID
- PBK-1701TC_P3
- Status last verified
- Nov 2018
- First submitted
- 11 Apr 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK-1701TC
- ClinicalTrials.gov ID
- NCT03509220
- Acronym / sponsor ID
- PBK-1701TC_P3
- Keywords
- Colonoscopy, PBK-1701TC, Bowel cleansing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBK-1701TC | Experimental | Drug: PBK-1701TC2-Day Split-Dosing Regimen |
| Standard oral preparation | Active comparator | Drug: Standard oral preparation2-Day Split-Dosing Regimen |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who is informed and give a consent in voluntary
- Patients who is scheduled a colonoscopy
- BMI 19≤and<30
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBK-1701TCThe subject will receive PBK-1701TC for colonoscopy. | Drug | PBK-1701TC |
| Standard oral preparationThe subject will receive the standard oral preparation for colonoscopy | Drug | Standard oral preparation |
Primary outcome
Successful cleansing rate
Time frame: Two days (from day of first dosing to day of colonoscopy)
%Patient with HCS-graded A or B
7 secondary outcomes
Overall cleansing rate
Time frame: Two days (from day of first dosing to day of colonoscopy)
Mean segmental cleansing score
Time frame: Two days (from day of first dosing to day of colonoscopy)
Mean cecal intubation time
Time frame: Two days (from day of first dosing to day of colonoscopy)
Mean colonoscopy withdrawal time
Time frame: Two days (from day of first dosing to day of colonoscopy)
Treatment compliance
Time frame: Two days (from day of first dosing to day of colonoscopy)
Patient satisfaction
Time frame: Two days (from day of first dosing to day of colonoscopy)
Polyp detection rate
Time frame: Two days (from day of first dosing to day of colonoscopy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PBK-1701TC and Standard oral preparation in people with Colonic Diseases and Intestinal Disease, run by Pharmbio Korea Co., Ltd. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful cleansing rate (time frame: Two days (from day of first dosing to day of colonoscopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.