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

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ClinicalTrials.gov Identifier: NCT02761213
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
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).


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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


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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02761213


Locations
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Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-040
Sponsors and Collaborators
Bo-In Lee
Pharmbio Korea Co., Ltd.
Investigators
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Study Director: Bo-In Lee, MD, PhD Seoul St. Mary's Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bo-In Lee, MD, PhD, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02761213     History of Changes
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
Additional relevant MeSH terms:
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Ascorbic Acid
Pharmaceutical Solutions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances