CClinicalTrials.gg
CompletedNCT01919255Updated Mar 26, 2015

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

A Phase 2 interventional study of Picolight + Coolprep and Picolight + Clicolon in Healthy, sponsored by National Cancer Center, Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Screening

Phase
Phase 2
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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]

02

Conditions studied

  • Healthy

Keywords

  • Colonoscopy
  • Bowel preparation
  • Picolight
  • Clicolon
  • Coolprep
03

In context

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 20-65 years of age
  • Elective colonoscopy of outpatients(consent to the study)

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
236 participants (actual)

Study arms

  • Active comparator
    Picolight + Coolprep (Day-Prior)

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

    Drug: Picolight + Coolprep

  • Active comparator
    Picolight + Clicolon (Day-Prior)

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

    Drug: Picolight + Clicolon

  • Active comparator
    Picolight + Coolprep (Split-Dose)

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

    Drug: Picolight + Coolprep

  • Active comparator
    Picolight + Clicolon (Split-Dose)

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

    Drug: Picolight + Clicolon

Interventions

  • DrugPicolight + Coolprep

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

    Also known as: Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate)

  • DrugPicolight + Clicolon

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

    Also known as: Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Clicolon(Sodium phosphate)

06

What researchers measure

Primary outcomes

  1. 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'.)

    Time frame: the day of colonoscopy

Secondary outcomes

  1. Patient tolerance

    Patient's tolerance; 1= "none"; 2= "mild"; 3= "bothersome"; 4= "distressing"; 5= "severely distressing"

    Time frame: the day of colonoscopy

Other outcomes

  1. Adenoma detection rate

    Adenoma detection rate (%)

    Time frame: The day of colonoscopy

07

Study locations

1 site
  • Dae Kyung Sohn
    Goyang-si, Gyeonggi-do 410-769, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01919255
Lead sponsor
National Cancer Center, Korea
Responsible party
Dae Kyung Sohn (MD., PHD, Center for Colorectal Cancer, National Cancer Center, Korea) — Principal investigator
First posted
Aug 8, 2013
Start date
Aug 2013
Primary completion
Sep 2014
Completion
Oct 2014
Last update
Mar 26, 2015

Study contacts

Dae Kyung Sohn
principal investigator · NCC,Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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