NCT06287606

Brief Summary

A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

February 23, 2024

Last Update Submit

November 26, 2024

Conditions

Bowel Preparation

Keywords

bowel preparation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day of scheduled colonoscopy

Secondary Outcomes (1)

  • Each segments ratio of subject with successful Bowel Cleansing

    1 day of scheduled colonoscopy

Other Outcomes (1)

  • Comparison of Acute gastropathy probability score

    1 day of scheduled colonoscopy

Study Arms (3)

CTP0302-A

EXPERIMENTAL

2 days split-dose

Drug: CTP0302-A

CTP0302-B

EXPERIMENTAL

One day dose

Drug: CTP0302-B

Conventional OST

ACTIVE COMPARATOR

2 days split-dose

Drug: Conventional OST

Interventions

CTP0302-ADRUG

Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.

Also known as: Treatment Group A
CTP0302-A
CTP0302-BDRUG

Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day

Also known as: Treatment Group B
CTP0302-B
Conventional OSTDRUG

Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.

Also known as: Control group
Conventional OST

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must provide written informed consent.
  • Male and female outpatients and inpatients aged: ≥19
  • Patients BMI shoule be ≤ 30

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taejoon Pharmaceutical Co., Ltd.

Seoul, Seoul, South Korea

Location

Related Publications (1)

  • 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. 2025 Nov 27. doi: 10.5009/gnl250291. Online ahead of print.

    PMID: 41306094DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jaemyung Cha, MD. PhD

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 1, 2024

Study Start

August 29, 2023

Primary Completion

January 4, 2024

Study Completion

January 4, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)