Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02761213
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : October 11, 2017
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
Bo-In Lee, Seoul St. Mary's Hospital

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.

Condition or disease Intervention/treatment Phase
Cathartic Colon Drug: Oral sulfate solution (OSS) Drug: 2-L PEG/Asc Phase 4

Detailed 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study
Study Start Date : April 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Oral sulfate solution (OSS)
oral sulfate solution (OSS)
Drug: Oral sulfate solution (OSS)
Oral sulfate solution (OSS)
Other Name: SUPREP

Active Comparator: 2-L PEG/Asc
low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc)
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.
Other Name: COOLPREP

Primary Outcome Measures :
  1. Boston Bowel Preparation Scale (BPPS) [ Time Frame: during colonoscopy ]
  2. Aronchick scale [ Time Frame: during colonoscopy ]
    Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon.

Secondary Outcome Measures :
  1. Tolerability by a patient questionnaire using 5-point Likert scale [ Time Frame: on arrival at the endoscopy unit before colonoscopy ]
    to assess tolerability of each bowel preparation

  2. Safety by measuring hemodynamic and biochemical data [ Time Frame: at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite ]
    Biochemical data will be measured only in case of necessity such as weakness, mental change or numbness.

  3. Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers [ Time Frame: during colonoscopy ]
  4. Percentage of cecal intubation [ Time Frame: during colonoscopy ]
  5. Insertion time [ Time Frame: during colonoscopy ]
  6. Withdrawal time [ Time Frame: during colonoscopy ]
  7. Adenoma detection rate [ Time Frame: during colonoscopy ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02761213

Layout table for location information
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-040
Sponsors and Collaborators
Bo-In Lee
Pharmbio Korea Co., Ltd.
Layout table for investigator information
Study Director: Bo-In Lee, MD, PhD Seoul St. Mary's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bo-In Lee, MD, PhD, Seoul St. Mary's Hospital Identifier: NCT02761213    
Other Study ID Numbers: KC16MISV0004
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No