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

National Cancer Center (NCC)

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Picolight + Clicolon; Drug: Picolight + Coolprep

Study type: Interventional

Funder types: Other

Identifiers

NCT01919255

NCC-CAN-001

Details and patient eligibility

About

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

Full description

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]

Enrollment: 236 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 4 patient groups

Picolight + Coolprep (Day-Prior)

Active Comparator group

Description:

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

Treatment:

Drug: Picolight + Coolprep

Picolight + Clicolon (Day-Prior)

Active Comparator group

Description:

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

Treatment:

Drug: Picolight + Clicolon

Picolight + Coolprep (Split-Dose)

Active Comparator group

Description:

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

Treatment:

Drug: Picolight + Coolprep

Picolight + Clicolon (Split-Dose)

Active Comparator group

Description:

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

Treatment:

Drug: Picolight + Clicolon