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
|Condition or disease||Intervention/treatment||Phase|
|Cathartic Colon||Drug: Oral sulfate solution (OSS) Drug: 2-L PEG/Asc||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Boston Bowel Preparation Scale (BPPS) [ Time Frame: during colonoscopy ]
- 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.
- 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
- 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.
- Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers [ Time Frame: during colonoscopy ]
- Percentage of cecal intubation [ Time Frame: during colonoscopy ]
- Insertion time [ Time Frame: during colonoscopy ]
- Withdrawal time [ Time Frame: during colonoscopy ]
- Adenoma detection rate [ Time Frame: during colonoscopy ]
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
|Korea, Republic of|
|Seoul St. Mary's Hospital|
|Seoul, Korea, Republic of, 137-040|
|Study Director:||Bo-In Lee, MD, PhD||Seoul St. Mary's Hospital|