Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05870553
Other study ID # CTP0301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 30, 2023
Est. completion date May 12, 2023

Study information

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

Clinical Trial Summary

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 Completed
Enrollment 137
Est. completion date May 12, 2023
Est. primary completion date May 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: - Male and female outpatients and inpatients aged: =19 - A prospective colonoscopy person - Written informed consent to participate in the trial 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CTP0301-A
Bowel Preparation
CTP0301-B
Bowel Preparation
Cool prep
Bowel Preparation

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
Primary 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 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. 1 day of scheduled colonoscopy
See also
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT05670470 - A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial Phase 3
Not yet recruiting NCT02536729 - Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome N/A
Completed NCT02093156 - A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy N/A
Completed NCT00831064 - A Trial of Four Different Bowel Cleansing Regimens Prior to Colonoscopy N/A
Completed NCT06141122 - The Colonoscopy Booklet:Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience N/A
Recruiting NCT05137145 - Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation N/A
Recruiting NCT04591145 - Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System
Completed NCT05088408 - Comparative Study Between Colonoscopy Bowel Preparation With Clear Liquids, With and Without Two Servings of High Energy Nutritional Supplement Phase 4
Completed NCT04605432 - FFI and PR Could Improve Bowel Cleansing. N/A
Withdrawn NCT04087265 - Accuracy of Trans-abdominal Ultrasound in Evaluating Bowel Preparation Adequacy Before Colonoscopy N/A
Recruiting NCT06051955 - Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing N/A
Recruiting NCT05609591 - Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children N/A
Completed NCT02979223 - Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation Phase 2
Completed NCT02290093 - Bowel Preparation for Colonoscopy in the Elderly Phase 4
Completed NCT01513096 - Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation Phase 3
Completed NCT03704571 - A Predictive Model for Inadequate Bowel Preparation N/A
Recruiting NCT06438237 - Validation of a Prediction Model for Inadequate Bowel Preparation
Recruiting NCT05041283 - Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy N/A
Recruiting NCT02761317 - Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery Phase 4