Clinical Trials Logo
  1. Home
  2. Bowel Preparation
  3. NCT03544944
  4. Details
NCT03544944 Clinical Trial

A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

Bowel Preparation Clinical Trial

Official title:
A Prospective, Randomized, Single-blinded (Evaluator), Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03544944
Other study ID # TJP-008-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2, 2018
Est. completion date July 30, 2018

Study information
Verified date April 2018
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 297
Est. completion date July 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 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 within last 12 months or current episode of severe constipation

- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.

- Known phenylketonuria.

- Clinically relevant findings on physical examination based on the Investigator's judgment.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TJP-008-1
Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
• TJP-008-2
Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
• Coolprep powder
Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next 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
Primary Ratio of subjects With successful Bowel Cleansing 1 day of scheduled colonoscopy
Secondary Easch segments ratio of subject with successful Bowel Cleansing 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 NCT04605432 - FFI and PR Could Improve Bowel Cleansing. N/A
Completed NCT05088408 - Comparative Study Between Colonoscopy Bowel Preparation With Clear Liquids, With and Without Two Servings of High Energy Nutritional Supplement Phase 4
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