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Completed

NCT Number: NCT06287606

A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy

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

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taejoon Pharmaceutical Co., Ltd.

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CTP0302-A

Drug

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

Other names: Treatment Group A

CTP0302-B

Drug

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

Other names: Treatment Group B

Conventional OST

Drug

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

Other names: Control group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Each segments ratio of subject with successful Bowel Cleansing

    Time frame: 1 day of scheduled colonoscopy

    Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc.

Other outcomes

  1. Comparison of Acute gastropathy probability score

    Time frame: 1 day of scheduled colonoscopy

    According to 'The Manual of Gastric Mucosal Assessment', it's graded on a scale of 'Possible' to 'Very likely'.

Sponsors and collaborators

Lead sponsor

Taejoon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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