Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation

Study Overview
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Brief Summary
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The purpose of this study to bowel cleansing evaluation of mixed two other type bowel preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).

Detailed Description
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To evaluate mixed-drug bowel preparation methods for decreasing side effect and increasing compliance Picolight + Coolprep [Day-Prior] Picolight + Clicolon [Day-Prior] Picolight + Coolprep [Split-Dose] Picolight + Clicolon [Split-Dose]

Official Title
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Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Picolight + Coolprep
* Drug: Picolight + Clicolon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-65 years of age Elective colonoscopy of outpatients(consent to the study) Exclusion Criteria: Active enteritis, enteric bleeding, obstruction Pregnant or lactating women Severe liver or renal insufficiency Allergic to any preparation components History of heart disease (ischemic heart disease, congestive heart failure, arrythmia) History of colorectal surgery History abdominal surgery within 6 month Toxic colitis or megacolon Nausea or vomiting Status emergent abdominal surgery (ex. acute appendicitis) Uncontrolled clinically significant pre-existing electrolyte disturbance Dehydration Phenylketonuria Glucose-6-phosphate dehydrogenase deficiency Ileus Suspicious hyperphosphatemia Acute phosphate nephropathy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Picolight + Coolprep (Day-Prior)<br>Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] | Drug: Picolight + Coolprep<br>* Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose]<br>* Other names: Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate);|
| Active Comparator: Picolight + Clicolon (Day-Prior)<br>Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] | Drug: Picolight + Clicolon<br>* Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose]<br>* Other names: Clicolon(Sodium phosphate);|
| Active Comparator: Picolight + Coolprep (Split-Dose)<br>Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose] | Drug: Picolight + Coolprep<br>* Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose]<br>* Other names: Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate);|
| Active Comparator: Picolight + Clicolon (Split-Dose)<br>Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose] | Drug: Picolight + Clicolon<br>* Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose]<br>* Other names: Clicolon(Sodium phosphate);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation quality | Aronchick bowel preparation score; Excellent: small volume of clear liquid or greater than 95% of surface seen Good: large volume of clear liquid 5% to 25% of the surface but greater than 90% of surface seen Fair: some semi-solid stool that could be suctioned or washed away, but greater than 90% of surface seen Poor: semi-solid stool that could not be suctioned or washed away and less than 90% of surface seen Inadequate: re-preparation needed (* 'success' of bowel preparation is defined as Aronchick's 'Excellent' or 'Good'.) | the day of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerance | Patient's tolerance; 1= none; 2= mild; 3= bothersome; 4= distressing; 5= severely distressing | the day of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Bowel preparation, Picolight, Clicolon, Coolprep