Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation

Study Overview
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Brief Summary
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Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation. For bowel preparation, effective, well-tolerated and safe methods should be applied. Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation

Detailed Description
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For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation

Official Title
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Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)

Conditions
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Healthy

Intervention / Treatment
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* Drug: HAPREP®
* Drug: SUCLEAR®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age, between 20 and 75 Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy Exclusion Criteria: Gastrointestinal obstruction Bowel perforation Gastric retention Ileus Toxic colitis or toxic megacolon Known allergies to components of the OSS and PEG-Asc History of colorectal resection History of abdominopelvic surgery within 6 months uncontrolled electrolyte imbalance hereditary Phenylketonuria Severe dehydration status seizure coma Glucose-6-phosphate dehydrogenase deficiency

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HAPREP® (PEG-Asc)<br>subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy] | Drug: HAPREP®<br>* Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc) : : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]<br>* Other names: 2L polyethylene glycol with ascorbic acidl PEG-Asc;|
| Experimental: SUCLEAR® (OSS)<br>subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation : OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy] | Drug: SUCLEAR®<br>* Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]<br>* Other names: oral sulfate solution; OSS,;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of bowel preparation |  | on the day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-point scale symptom questionnaire for drug tolerability | 4(distressing) or 5(severely distressing) point would be untolerable | on the day of colonoscopy | 
| Number of Participants with Adverse Events |  | on the day of colonoscopy | 
| colonoscopy insertion time |  | on the day of colonoscopy | 
| adenoma detection rate |  | whithin 3 weeks from the day of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyethylene glycol with ascorbic acid, oral sulfate solution, bowel preparation