Bowel PreparationPhase 3NCT05870553
A Phase 3 Trial in Bowel Preparation for Colonoscopy
A Phase 3 study testing CTP0301-A, CTP0301-B and Cool prep 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 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- CTP0301-A, CTP0301-B and Cool prep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2023to 12 May 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female outpatients and inpatients aged: ≥19
- A prospective colonoscopy person
- Written informed consent to participate in the trial
Who cannot join
- Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- Patients with ongoing severe acute Inflammatory Bowel Disease.
- Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
- Pregnant women or pregnant women or pregnant women
- Severe heart disease (cardiac failure (NYHA class 3 and 4))
- Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
- People who have hypersensitivity or allergies to clinical trial drug components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy.
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
- CTP0301-A, CTP0301-B, Cool prep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP0301-ADrug
Also called PEG 3350
Bowel Preparation
CTP0301-BDrug
Also called PEG 3350
Bowel Preparation
Cool prepDrug
Also called PEG 3350
Bowel Preparation
| Study group | Role | What they receive |
|---|---|---|
| CTP0301-A | Experimental | Subjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy. Receives: Drug: CTP0301-A |
| CTP0301-B | Experimental | Subjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy. Receives: Drug: CTP0301-B |
| Cool prep | Active comparator | Subjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy. Receives: Drug: Cool prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Successful Bowel Cleansing (Overall Colon)
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful.
Measured: 1 day of scheduled colonoscopy
Secondary outcomes (1)
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS.
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 posted23 May 2023
- Study start30 Jan 2023
- Primary completion12 May 2023
- Study completion12 May 2023
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
- 137 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
- NCT05870553
- Sponsor's protocol ID
- CTP0301
- Status last verified
- Feb 2024
- First submitted
- 21 Apr 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. 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
- NCT05870553
- Acronym / sponsor ID
- CTP0301
- Conditions
- Bowel Preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 23 May 2023 (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 |
|---|---|---|
| CTP0301-A | Experimental | Drug: CTP0301-ASubjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy. |
| CTP0301-B | Experimental | Drug: CTP0301-BSubjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy. |
| Cool prep | Active comparator | Drug: Cool prepSubjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female outpatients and inpatients aged: ≥19
- A prospective colonoscopy person
- Written informed consent to participate in the trial
Key exclusion criteria (7 listed)
- Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- Patients with ongoing severe acute Inflammatory Bowel Disease.
- Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
- Pregnant women or pregnant women or pregnant women
- Severe heart disease (cardiac failure (NYHA class 3 and 4))
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 |
|---|---|---|
| CTP0301-AAlso: PEG 3350Bowel Preparation | Drug | CTP0301-A |
| CTP0301-BAlso: PEG 3350Bowel Preparation | Drug | CTP0301-B |
| Cool prepAlso: PEG 3350Bowel Preparation | Drug | Cool prep |
Primary outcome
Number of Patients With Successful Bowel Cleansing (Overall Colon)
Time frame: 1 day of scheduled colonoscopy
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful.
1 secondary outcome
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
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 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 CTP0301-A, CTP0301-B and Cool prep 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 7 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 28 Feb 2024. 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?
Number of Patients With Successful Bowel Cleansing (Overall Colon) (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 28 Feb 2024.