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Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation

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ClinicalTrials.gov Identifier: NCT02979223
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Byung Chang KIM, National Cancer Center, Korea

Study Description
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Brief Summary:

The aim of this study is to compare the efficacy depending on the order of the sequential combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic acid for bowel preparation.

The investigators designed this study as a phase II prospective randomized parallel arm clinical trial. 71 participant will be enrolled in each group (142 in total).

The primary outcome is the efficacy of bowel preparation. secondary outcomes are tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.


Condition or disease Intervention/treatment Phase
Bowel Preparation Sodium Picosulfate and Magnesium Citrate Polyethylene Glycol With Ascorbic Acid Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)
Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
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Arm Intervention/treatment
Experimental: PMC/PEG-Asc
Picolyte 1 bottle/170cc at one day before colonoscopy, 7 PM. And then, Intake Coolprep 1L at the day of colonoscopy, 5 AM
 Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.

There is a difference in the order of intake between two group

Other Names:
  • Picosolution
  • Coolprep
Active Comparator: PEG-Asc/PMC
Intake Coolprep 1L at one day before colonoscopy, 7 PM. And then, Intake Picolyte 1 bottle/170cc at the day of colonoscopy, 5AM
 Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.

There is a difference in the order of intake between two group

Other Names:
  • Picosolution
  • Coolprep


Outcome Measures
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Primary Outcome Measures :
  1. Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score) [ Time Frame: during colonoscopy ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who agreed to participate in this study

Exclusion Criteria:

  • pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate < 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing electrolyte disturbances, symptomatic congestive heart failure, recent (within < 6 months) symptomatic ischemic heart disease (unstable angina or myocardial infarction).

toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria Patients with a history of colon surgery Abdominal operation within 6 months

Contacts and Locations
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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): NCT02979223


Locations
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Korea, Republic of
Bun Kim
Goyang, Gyeonggi-do, Korea, Republic of, 10408
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Bun Kim, Dr National Cancer Center, Korea
More Information
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Responsible Party: Byung Chang KIM, Principle investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02979223    
Other Study ID Numbers: NCC2016-0166
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ascorbic Acid
Picosulfate sodium
Magnesium citrate
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients
Cathartics
Gastrointestinal Agents