NCT05670470

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2022

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

September 21, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 1, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 2, 2023

Last Update Submit

February 28, 2023

Conditions

Bowel Preparation

Keywords

Bowel Preparation

Outcome Measures

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.

    1 day of scheduled colonoscopy

Secondary Outcomes (2)

  • Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)

    1 day of scheduled colonoscopy

  • Adenoma/Polyp Detection Rate (Overall Colon)

    1 day of scheduled colonoscopy

Study Arms (2)

CTP0303

EXPERIMENTAL
Drug: CTP0303

Orafang Tab

ACTIVE COMPARATOR
Drug: Orafang Tab

Interventions

CTP0303DRUG

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

CTP0303
Orafang TabDRUG

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

Orafang Tab

Eligibility Criteria

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

You may qualify if:

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

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, 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))
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong, 05278, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 37542674DERIVED

Study Officials

  • Jae Myung Cha, MD, PhD

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

September 21, 2022

Primary Completion

January 15, 2023

Study Completion

January 31, 2023

Last Updated

March 1, 2023

Record last verified: 2023-01

Locations

KR(1)