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

B

Bo-In Lee

Status and phase

Completed
Phase 4

Conditions

Cathartic Colon

Treatments

Drug: 2-L PEG/Asc
Drug: Oral sulfate solution (OSS)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02761213
KC16MISV0004

Details and patient eligibility

About

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.

Full description

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).

Enrollment

200 patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Oral sulfate solution (OSS)
Experimental group
Description:
oral sulfate solution (OSS)
Treatment:
Drug: Oral sulfate solution (OSS)
2-L PEG/Asc
Active Comparator group
Description:
low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc)
Treatment:
Drug: 2-L PEG/Asc

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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