NCT02761213

Brief Summary

The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

April 22, 2016

Last Update Submit

October 10, 2017

Conditions

Cathartic Colon

Outcome Measures

Primary Outcomes (2)

  • Boston Bowel Preparation Scale (BPPS)

    during colonoscopy

  • Aronchick scale

    Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon.

    during colonoscopy

Secondary Outcomes (7)

  • Tolerability by a patient questionnaire using 5-point Likert scale

    on arrival at the endoscopy unit before colonoscopy

  • Safety by measuring hemodynamic and biochemical data

    at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite

  • Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers

    during colonoscopy

  • Percentage of cecal intubation

    during colonoscopy

  • Insertion time

    during colonoscopy

  • +2 more secondary outcomes

Study Arms (2)

Oral sulfate solution (OSS)

EXPERIMENTAL

oral sulfate solution (OSS)

Drug: Oral sulfate solution (OSS)

2-L PEG/Asc

ACTIVE COMPARATOR

low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc)

Drug: 2-L PEG/Asc

Interventions

Oral sulfate solution (OSS)DRUG

Oral sulfate solution (OSS)

Also known as: SUPREP
Oral sulfate solution (OSS)
2-L PEG/AscDRUG

Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.

Also known as: COOLPREP
2-L PEG/Asc

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • people who receive colonoscopy
  • aged : 18-80
  • people who sign the consent

You may not qualify if:

  • those aged over 80 years
  • the disabled
  • intestinal obstruction
  • severe constipation
  • previous history of bowel resection
  • liver cirrhosis
  • heart failure or ischemic heart disease within 6 months
  • inflammatory bowel disease
  • pregnant women
  • severe renal insufficiency
  • people who refuse to sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137-040, South Korea

Location

Related Publications (4)

  • Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85. doi: 10.1111/j.1572-0241.2006.00673.x. No abstract available.

    PMID: 16635231BACKGROUND

  • Bannas P, Bakke J, Patrick JL, Pickhardt PJ. Automated volumetric analysis for comparison of oral sulfate solution (SUPREP) with established cathartic agents at CT colonography. Abdom Imaging. 2015 Jan;40(1):11-8. doi: 10.1007/s00261-014-0186-x.

    PMID: 24965898BACKGROUND

  • Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.

    PMID: 25028274BACKGROUND

  • Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.

    PMID: 30308546DERIVED

Study Officials

  • Bo-In Lee, MD, PhD

    Seoul St. Mary's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 4, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)