A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06287606
• Other study ID #: CTP0302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 29, 2023
• Est. completion date: May 14, 2024

Study information

• Verified date: February 2024
• Source: Taejoon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 161
• Est. completion date: May 14, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• CTP0302-A
Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.
• CTP0302-B
Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day
• Conventional OST
Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.

Locations

Country	Name	City	State
Korea, Republic of	Taejoon Pharmaceutical Co., Ltd.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taejoon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of Acute gastropathy probability score	According to 'The Manual of Gastric Mucosal Assessment', it's graded on a scale of 'Possible' to 'Very likely'.	1 day of scheduled colonoscopy
Primary	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	Each segments ratio of subject with successful Bowel Cleansing	Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc.	1 day of scheduled colonoscopy