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CompletedNCT05870553Updated Feb 28, 2024

A Phase 3 Trial in Bowel Preparation for Colonoscopy

A Phase 3 interventional study of CTP0301-A and CTP0301-B in Bowel Preparation, sponsored by Taejoon Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Taejoon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Bowel Preparation
03

In context

Lead sponsor

Taejoon Pharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female outpatients and inpatients aged: ≥19
  • A prospective colonoscopy person
  • Written informed consent to participate in the trial

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
137 participants (actual)

Study arms

  • Experimental
    CTP0301-A

    Subjects who are randomized into this group will take CTP0301-A from the evening before colonoscopy to the morning of colonoscopy.

    Drug: CTP0301-A

  • Experimental
    CTP0301-B

    Subjects who are randomized into this group will take CTP0301-B before the morning of colonoscopy.

    Drug: CTP0301-B

  • Active comparator
    Cool prep

    Subjects who are randomized into this group will take Cool prep from the evening before colonoscopy to the morning of colonoscopy.

    Drug: Cool prep

Interventions

  • DrugCTP0301-A

    Bowel Preparation

    Also known as: PEG 3350

  • DrugCTP0301-B

    Bowel Preparation

    Also known as: PEG 3350

  • DrugCool prep

    Bowel Preparation

    Also known as: PEG 3350

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day of scheduled colonoscopy

Secondary outcomes

  1. 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.

    Time frame: 1 day of scheduled colonoscopy

07

Study locations

1 site
  • Taejoon Pharmaceutical Co., Ltd.
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05870553
Lead sponsor
Taejoon Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 23, 2023
Start date
Jan 30, 2023
Primary completion
May 12, 2023
Completion
May 12, 2023
Last update
Feb 28, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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