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

NCT02979223 | Completed Phase 2

• 1 other identifier: NCC2016-0166
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation; Sodium Picosulfate and Magnesium Citrate; Polyethylene Glycol With Ascorbic Acid

Outcome Measures

Primary Outcomes (1)

• Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score)

  during colonoscopy

Study Arms (2)

PMC/PEG-Asc

EXPERIMENTAL

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

PEG-Asc/PMC

ACTIVE COMPARATOR

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

Interventions

sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid DRUG

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

Also known as: Picosolution, Coolprep

PEG-Asc/PMC; PMC/PEG-Asc

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

Bun Kim

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

MeSH Terms

Interventions

picosulfate sodium; magnesium citrate; Polyethylene Glycols; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Bun Kim, Dr

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 1, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)