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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Picolight + Coolprep; Drug: Picolight + Clicolon

• Registration Number: NCT01919255
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-08
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Picolight + Coolprep (Day-Prior)	Picolight + Coolprep	Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)\[Day-Prior\]
Picolight + Clicolon (Day-Prior)	Picolight + Clicolon	Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) \[Day-Prior\]
Picolight + Coolprep (Split-Dose)	Picolight + Coolprep	Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)\[Split-Dose\]
Picolight + Clicolon (Split-Dose)	Picolight + Clicolon	Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)\[Split-Dose\]

Primary Outcome Measures

Name	Time	Method
Bowel preparation quality	the day of colonoscopy	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'.)

Secondary Outcome Measures

Name	Time	Method
Patient tolerance	the day of colonoscopy	Patient's tolerance; 1= "none"; 2= "mild"; 3= "bothersome"; 4= "distressing"; 5= "severely distressing"

Trial Locations

Locations (1)

Dae Kyung Sohn; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of