NCT01919255

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for phase_2 healthy

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

August 3, 2013

Last Update Submit

March 25, 2015

Conditions

Healthy

Keywords

ColonoscopyBowel preparationPicolightClicolonCoolprep

Outcome Measures

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'.)

    the day of colonoscopy

Secondary Outcomes (1)

  • Patient tolerance

    the day of colonoscopy

Other Outcomes (1)

  • Adenoma detection rate

    The day of colonoscopy

Study Arms (4)

Picolight + Coolprep (Day-Prior)

ACTIVE COMPARATOR

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

Drug: Picolight + Coolprep

Picolight + Clicolon (Day-Prior)

ACTIVE COMPARATOR

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

Drug: Picolight + Clicolon

Picolight + Coolprep (Split-Dose)

ACTIVE COMPARATOR

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

Drug: Picolight + Coolprep

Picolight + Clicolon (Split-Dose)

ACTIVE COMPARATOR

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

Drug: Picolight + Clicolon

Interventions

Picolight + CoolprepDRUG

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)
Picolight + Coolprep (Day-Prior)Picolight + Coolprep (Split-Dose)
Picolight + ClicolonDRUG

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)
Picolight + Clicolon (Day-Prior)Picolight + Clicolon (Split-Dose)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dae Kyung Sohn

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Interventions

Magnesium Oxidepicosulfate sodiumsodium sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Dae Kyung Sohn

    NCC,Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., PHD, Center for Colorectal Cancer

Study Record Dates

First Submitted

August 3, 2013

First Posted

August 8, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

KR(1)