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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01919255

Enrollment

236

Registered

2013-08-08

Start date

2013-08-31

Completion date

2014-10-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Colonoscopy, Bowel preparation, Picolight, Clicolon, Coolprep

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 \[Split-Dose\]

Interventions

DRUGPicolight + Coolprep

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

DRUGPicolight + Clicolon

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Other

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026