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Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid

NCT ID: NCT02761213

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.

Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.

In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).

Conditions

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Cathartic Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Oral sulfate solution (OSS)

oral sulfate solution (OSS)

Group Type EXPERIMENTAL

Oral sulfate solution (OSS)

Intervention Type DRUG

Oral sulfate solution (OSS)

2-L PEG/Asc

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

Group Type ACTIVE_COMPARATOR

2-L PEG/Asc

Intervention Type DRUG

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

Interventions

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Oral sulfate solution (OSS)

Oral sulfate solution (OSS)

Intervention Type DRUG

2-L PEG/Asc

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

Intervention Type DRUG

Other Intervention Names

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SUPREP COOLPREP

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pharmbio Korea Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Bo-In Lee

OTHER

Sponsor Role lead

Responsible Party

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Bo-In Lee

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bo-In Lee, MD, PhD

Role: STUDY_DIRECTOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 16635231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24965898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25028274 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30308546 (View on PubMed)

Other Identifiers

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KC16MISV0004

Identifier Type: -

Identifier Source: org_study_id