NCT02551198

Brief Summary

Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation. For bowel preparation, effective, well-tolerated and safe methods should be applied. Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Nov 2015

Typical duration for phase_3 healthy

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

First Submitted

Initial submission to the registry

September 11, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

September 11, 2015

Last Update Submit

January 15, 2019

Conditions

Healthy

Keywords

polyethylene glycol with ascorbic acidoral sulfate solutionbowel preparation

Outcome Measures

Primary Outcomes (1)

  • Adequacy of bowel preparation

    on the day of colonoscopy

Secondary Outcomes (4)

  • 5-point scale symptom questionnaire for drug tolerability

    on the day of colonoscopy

  • Number of Participants with Adverse Events

    on the day of colonoscopy

  • colonoscopy insertion time

    on the day of colonoscopy

  • adenoma detection rate

    whithin 3 weeks from the day of colonoscopy

Study Arms (2)

HAPREP® (PEG-Asc)

ACTIVE COMPARATOR

subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation : PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]

Drug: HAPREP®

SUCLEAR® (OSS)

EXPERIMENTAL

subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation : OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]

Drug: SUCLEAR®

Interventions

HAPREP®DRUG

Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc) : : PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]

Also known as: 2L polyethylene glycol with ascorbic acidl PEG-Asc
HAPREP® (PEG-Asc)
SUCLEAR®DRUG

Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]

Also known as: oral sulfate solution; OSS,
SUCLEAR® (OSS)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age, between 20 and 75
  • Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy

You may not qualify if:

  • Gastrointestinal obstruction
  • Bowel perforation
  • Gastric retention
  • Ileus
  • Toxic colitis or toxic megacolon
  • Known allergies to components of the OSS and PEG-Asc
  • History of colorectal resection
  • History of abdominopelvic surgery within 6 months
  • uncontrolled electrolyte imbalance
  • hereditary Phenylketonuria
  • Severe dehydration status
  • seizure
  • coma
  • Glucose-6-phosphate dehydrogenase deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

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

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Dae Kyung Sohn, M.D.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 16, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

September 1, 2017

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

KR(1)