Bowel PreparationPhase 3NCT03544944
A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
A Phase 3 study testing TJP-008-1, TJP-008-2 and Coolprep powder in people with Bowel Preparation, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- TJP-008-1, TJP-008-2 and Coolprep powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2018to 30 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must provide written informed consent.
- Male and female outpatients and inpatients aged: ≥19
- Patients BMI shoule be ≤ 30
Who cannot join
- Patients with past history within last 12 months or current episode of severe constipation
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Known phenylketonuria.
- Clinically relevant findings on physical examination based on the Investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
- Conditions
- Bowel Preparation
- Being tested
- TJP-008-1, TJP-008-2, Coolprep powder
- Keywords
- bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJP-008-1Drug
Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
TJP-008-2Drug
Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
Coolprep powderDrug
Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.
| Study group | Role | What they receive |
|---|---|---|
| TJP-008-1 | Experimental | Not described Receives: Drug: TJP-008-1 |
| TJP-008-2 | Experimental | Not described Receives: Drug: TJP-008-2 |
| Coolprep powder | Active comparator | Not described Receives: Drug: Coolprep powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of subjects With successful Bowel Cleansing
Measured: 1 day of scheduled colonoscopy
Secondary outcomes (1)
Easch segments ratio of subject with successful Bowel Cleansing
Measured: 1 day of scheduled colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start2 Jan 2018
- Primary completion30 May 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544944
- Sponsor's protocol ID
- TJP-008-301
- Status last verified
- Apr 2018
- First submitted
- 22 May 2018
- Last updated
- 4 Sep 2019
- 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 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT03544944
- Acronym / sponsor ID
- TJP-008-301
- Conditions
- Bowel Preparation
- Keywords
- bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 4 Jun 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 is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TJP-008-1 | Experimental | Drug: TJP-008-1 |
| TJP-008-2 | Experimental | Drug: TJP-008-2 |
| Coolprep powder | Active comparator | Drug: Coolprep powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must provide written informed consent.
- Male and female outpatients and inpatients aged: ≥19
- Patients BMI shoule be ≤ 30
Key exclusion criteria (4 listed)
- Patients with past history within last 12 months or current episode of severe constipation
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Known phenylketonuria.
- Clinically relevant findings on physical examination based on the Investigator's judgment.
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 |
|---|---|---|
| TJP-008-1Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day. | Drug | TJP-008-1 |
| TJP-008-2Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning. | Drug | TJP-008-2 |
| Coolprep powderSubjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning. | Drug | Coolprep powder |
Primary outcome
Ratio of subjects With successful Bowel Cleansing
Time frame: 1 day of scheduled colonoscopy
1 secondary outcome
Easch segments ratio of subject with successful Bowel Cleansing
Time frame: 1 day of scheduled 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 4 Sep 2019.
Related trials for Bowel Preparation
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
RecruitingPhase 4
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TJP-008-1, TJP-008-2 and Coolprep powder in people with Bowel Preparation, run by Taejoon Pharmaceutical Co., Ltd. at 1 site 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 4 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Ratio of subjects With successful Bowel Cleansing (time frame: 1 day of scheduled 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 4 Sep 2019.