Bowel PreparationPhase 3PROPELLERNCT05670470

A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial

A Phase 3 study testing CTP0303 and Orafang Tab in people with Bowel Preparation, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective randomized study compared with active control arm. 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?: CTP0303 and Orafang Tab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteSouth Korea
Study dates: 21 Sep 2022to 31 Jan 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 years and older
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, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
Pregnant women or pregnant women or pregnant women
Patients who have not been confirmed to have COVID-19 for a month
Severe heart disease (cardiac failure (NYHA class 3 and 4))

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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
Patients with severe chronic renal impairment (glomerular filtration rate less than 30ml/min/1.73m2)
People who have hypersensitivity or allergies to clinical trial drug components

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Kyung Hee University Hospital at Gangdong
Seoul, Gangdong, 05278

Other trials in South Korea

About this study

Official title: A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

This is a prospective randomized study compared with active control arm.

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: CTP0303, Orafang Tab
Keywords: Bowel Preparation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTP0303Drug
Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.
Orafang TabDrug
Subjects who are randomized into group Orafang Tab will receive bowel preparation from evening to next morning.

Study groups in NCT05670470
Study group	Role	What they receive
CTP0303	Experimental	Not described Receives: Drug: CTP0303
Orafang Tab	Active comparator	Not described Receives: Drug: Orafang Tab

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 (2)

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
Adenoma/Polyp Detection Rate (Overall Colon)
Through colonoscopy, a blinded central reader checks whether polyp or adenoma is found, and if more than one polyp or adenoma is found in a patient, it is defined as "detection." The polyp detection rate (PDR) and adenoma detection rate (ADR) of the entire colon and ascending colon are defined as follows.
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.

21 Sep 202231 Jan 2023

First posted4 Jan 2023
Study start21 Sep 2022
Primary completion15 Jan 2023
Study completion31 Jan 2023

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: Single blind
Who is masked: Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05670470
Sponsor's protocol ID: CTP0303
Acronym: PROPELLER
Status last verified: Jan 2023
First submitted: 2 Jan 2023
Last updated: 1 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Jeon SR, Park SK, Yang DH, Cha JM. Comparison of a novel mini-oral sulfate tablet and the conventional oral sulfate tablet in bowel preparation for colonoscopy: a prospective, randomized, investigator-blinded, multicenter, non-inferior, phase 3 trial. J Gastroenterol. 2023 Nov;58(11):1114-1123. doi: 10.1007/s00535-023-02023-5. Epub 2023 Aug 5.
PubMed 37542674

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
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RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
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All Bowel Preparation trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2023. 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: NCT05670470
Acronym / sponsor ID: PROPELLER / CTP0303
Conditions: Bowel Preparation
Keywords: Bowel Preparation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Sep 2022 (actual)
Primary completion: 15 Jan 2023 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 4 Jan 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.

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: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CTP0303	Experimental	Drug: CTP0303
Orafang Tab	Active comparator	Drug: Orafang Tab

Who may qualify

Ages: 19 years and older
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 (9 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, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
Pregnant women or pregnant women or pregnant women
Patients who have not been confirmed to have COVID-19 for a month

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
CTP0303Subjects who are randomized into group CTP0303 will receive bowel preparation from evening to next morning.	Drug	CTP0303
Orafang TabSubjects who are randomized into group Orafang Tab will receive bowel preparation from evening to next morning.	Drug	Orafang Tab

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.

2 secondary outcomes

Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Time frame: 1 day of scheduled colonoscopy
Adenoma/Polyp Detection Rate (Overall Colon)
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 1 Mar 2023.
Derived from this study: PubMed 37542674Jeon SR, Park SK, Yang DH, Cha JM. Comparison of a novel mini-oral sulfate tablet and the conventional oral sulfate tablet in bowel preparation for colonoscopy: a prospective, randomized, investigator-blinded, multicenter, non-inferior, phase 3 trial. J Gastroenterol. 2023 Nov;58(11):1114-1123. doi: 10.1007/s00535-023-02023-5. Epub 2023 Aug 5.

Related trials for Bowel Preparation

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
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures

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.

Jae Myung 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 CTP0303 and Orafang Tab 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 9 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 1 Mar 2023. 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?

On the ClinicalTrials.gov record for NCT05670470, 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 1 Mar 2023.