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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Colonic Disease, Intestinal Disease

Intervention / Treatment
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* Drug: OST
* Drug: 2L-PEG/Asc


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, prospective, investigator single-blinded, randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OST<br>2 days split dosing regimen | Drug: OST<br>* The subject will receive Orafang for colonoscopy<br>|
| Active Comparator: 2L-PEG/Asc<br>2 days split dosing regimen | Drug: 2L-PEG/Asc<br>* The subject will receive 2L-PEG/Asc for colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful cleaning rate1 | %Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment | Two days (from day of first dosing to day of colonoscopy) | 
| Successful cleaning rate2 | %Patient with HCS-graded A or B | Two days (from day of first dosing to day of colonoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment compliance | %Patient who have completed taking the investigational products | Two days (from day of first dosing to day of colonoscopy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, orafang, bowel cleaning