Bowel PreparationPhase 3NCT06287606
A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy
A Phase 3 study testing CTP0302-A, CTP0302-B and Conventional OST in people with Bowel Preparation, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- CTP0302-A, CTP0302-B and Conventional OST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Aug 2023to 4 Jan 2024
- 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 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 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, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy
Read the detailed description
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
- CTP0302-A, CTP0302-B, Conventional OST
- Keywords
- bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP0302-ADrug
Also called Treatment Group A
Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.
CTP0302-BDrug
Also called Treatment Group B
Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day
Conventional OSTDrug
Also called Control group
Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.
| Study group | Role | What they receive |
|---|---|---|
| CTP0302-A | Experimental | 2 days split-dose Receives: Drug: CTP0302-A |
| CTP0302-B | Experimental | One day dose Receives: Drug: CTP0302-B |
| Conventional OST | Active comparator | 2 days split-dose Receives: Drug: Conventional OST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of subjects With successful Bowel Cleansing
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)
Each segments ratio of subject with successful Bowel Cleansing
Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc.
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 posted1 Mar 2024
- Study start29 Aug 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaemyung Cha, MD. PhD, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287606
- Sponsor's protocol ID
- CTP0302
- Status last verified
- Nov 2024
- First submitted
- 23 Feb 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park SK, Jeon SR, Yang DH, Chun J, Cha JM. Efficacy and Safety of Bowel Cleansing with Mini S-Oral Sulfate Tablet versus the Conventional Oral Sulfate Tablet: A Prospective, Randomized, Investigator-Blinded, Multicenter, Noninferior, Phase 3 Trial. Gut Liver. 2026 Mar 15;20(2):294-304. doi: 10.5009/gnl250291. Epub 2025 Nov 27.
PubMed 41306094
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT06287606
- Acronym / sponsor ID
- CTP0302
- Conditions
- Bowel Preparation
- Keywords
- bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 1 Mar 2024 (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.
A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy
Detailed description
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
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTP0302-A | Experimental | Drug: CTP0302-A2 days split-dose |
| CTP0302-B | Experimental | Drug: CTP0302-BOne day dose |
| Conventional OST | Active comparator | Drug: Conventional OST2 days split-dose |
Who may qualify
- Ages
- 19 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 (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 |
|---|---|---|
| CTP0302-AAlso: Treatment Group ASubjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning. | Drug | CTP0302-A |
| CTP0302-BAlso: Treatment Group BSubjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day | Drug | CTP0302-B |
| Conventional OSTAlso: Control groupSubjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning. | Drug | Conventional OST |
Primary outcome
Ratio of subjects With successful Bowel Cleansing
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
Each 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 29 Nov 2024.
- Derived from this study: PubMed 41306094Park SK, Jeon SR, Yang DH, Chun J, Cha JM. Efficacy and Safety of Bowel Cleansing with Mini S-Oral Sulfate Tablet versus the Conventional Oral Sulfate Tablet: A Prospective, Randomized, Investigator-Blinded, Multicenter, Noninferior, Phase 3 Trial. Gut Liver. 2026 Mar 15;20(2):294-304. doi: 10.5009/gnl250291. Epub 2025 Nov 27.
- 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.
Jaemyung Cha, MD. PhD principal investigator
Kyung Hee University Hospital at Gangdong
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 CTP0302-A, CTP0302-B and Conventional OST 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 29 Nov 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?
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?
On the ClinicalTrials.gov record for NCT06287606, which also lists 1 linked publication.
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 29 Nov 2024.