Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2024-02-29

Brief Summary

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This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.

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Detailed Description

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This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.

Conditions

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Colonic Disease Intestinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter, prospective, investigator single-blinded, randomized study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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OST

2 days split dosing regimen

Group Type EXPERIMENTAL

OST

Intervention Type DRUG

The subject will receive Orafang for colonoscopy

2L-PEG/Asc

2 days split dosing regimen

Group Type ACTIVE_COMPARATOR

2L-PEG/Asc

Intervention Type DRUG

The subject will receive 2L-PEG/Asc for colonoscopy

Interventions

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OST

The subject will receive Orafang for colonoscopy

Intervention Type DRUG

2L-PEG/Asc

The subject will receive 2L-PEG/Asc for colonoscopy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age over 70
* Patients who is scheduled a colonoscopy
* Patients who is informed and give a consent in voluntary

Exclusion Criteria

* History of colectomy
* Patients over American Society of Anesthesiology class III
* Patients who has difficulty swallowing
* In the case of abnormal findings requiring treatment in the basic blood test
* Patients with uncontrollable chronic diseases
* Patients suspected of having Paralytic ileus or intestinal obstruction.
* Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.)
* Patients who has a history of drug abuse and addiction
* Patients who for any reason, are deemed by the Investigator to be inappropriate for this study

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes