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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Picolight + Coolprep; Drug: Picolight + Clicolon

Detailed 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]

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • Dae Kyung Sohn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Adenoma detection rate (%)	The day of colonoscopy

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Dae Kyung Sohn, NCC,Korea

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 3, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (Estimate): August 8, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Colonoscopy; Bowel preparation; Picolight; Clicolon; Coolprep
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anticoagulants; Chelating Agents; Sequestering Agents; Cathartics; Calcium Chelating Agents; Antacids; Picosulfate sodium; Magnesium Oxide; Citric Acid; Sodium Citrate; Sodium sulfate
• Other Study ID Numbers: NCC-CAN-001