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

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

PHASE2

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-10-31

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).

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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 \[Split-Dose\]

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Picolight + Coolprep (Day-Prior)

Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)\[Day-Prior\]

Group Type ACTIVE_COMPARATOR

Picolight + Coolprep

Intervention Type DRUG

Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)\[Day-Prior\] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)\[Split-Dose\]

Picolight + Clicolon (Day-Prior)

Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) \[Day-Prior\]

Group Type ACTIVE_COMPARATOR

Picolight + Clicolon

Intervention Type DRUG

Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) \[Day-Prior\] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)\[Split-Dose\]

Picolight + Coolprep (Split-Dose)

Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)\[Split-Dose\]

Group Type ACTIVE_COMPARATOR

Picolight + Coolprep

Intervention Type DRUG

Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)\[Day-Prior\] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)\[Split-Dose\]

Picolight + Clicolon (Split-Dose)

Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)\[Split-Dose\]

Group Type ACTIVE_COMPARATOR

Picolight + Clicolon

Intervention Type DRUG

Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) \[Day-Prior\] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)\[Split-Dose\]

Interventions

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Picolight + Coolprep

Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)\[Day-Prior\] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)\[Split-Dose\]

Intervention Type DRUG

Picolight + Clicolon

Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) \[Day-Prior\] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)\[Split-Dose\]

Intervention Type DRUG

Other Intervention Names

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Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate) Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate) Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate) Clicolon(Sodium phosphate)

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes