A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2023-01-31

Brief Summary

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

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Detailed Description

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

Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CTP0303

Group Type EXPERIMENTAL

CTP0303

Intervention Type DRUG

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

Orafang Tab

Group Type ACTIVE_COMPARATOR

Orafang Tab

Intervention Type DRUG

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

Interventions

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CTP0303

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

Intervention Type DRUG

Orafang Tab

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

Intervention Type DRUG

Eligibility Criteria

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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, 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes