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

This study is currently recruiting participants.

See

Contacts and Locations

Verified December 2016 by Byung Chang KIM, National Cancer Center, Korea

Sponsor:

Information provided by (Responsible Party):

Byung Chang KIM, National Cancer Center, Korea

ClinicalTrials.gov Identifier:

NCT02979223

First received: November 29, 2016

Last updated: December 4, 2016

Last verified: December 2016

History of Changes

Purpose

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. 67 participant will be enrolled in each group (134 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	Intervention	Phase
Bowel Preperation Sodium Picosulfate and Magnesium Citrate Polyethylene Glycol With Ascorbic Acid	Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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)

Resource links provided by NLM:

MedlinePlus related topics: Vitamin C

Drug Information available for: Ascorbic acid Sodium ascorbate Sodium citrate Magnesium citrate Citric acid monohydrate Magnesium Polyethylene Sodium Picosulfate Magnesium ascorbate

U.S. FDA Resources

Further study details as provided by Byung Chang KIM, National Cancer Center, Korea:

Primary Outcome Measures:

Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score) [ Time Frame: during colonoscopy ]


Estimated Enrollment:	134
Study Start Date:	November 2016
Estimated Study Completion Date:	June 2017
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02979223

Contacts


Contact: Bun Kim, Dr	+82-31-920-1662	kimbun@ncc.re.kr

Locations


Korea, Republic of
Bun Kim	Recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 10408
Contact: Bun Kim, Dr +82-31-920-1662 kimbun@ncc.re.kr

Sponsors and Collaborators

National Cancer Center, Korea

Investigators


Principal Investigator:	Bun Kim, Dr	National Cancer Center, Korea

More Information


Responsible Party:	Byung Chang KIM, Principle investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT02979223 History of Changes
Other Study ID Numbers:	NCC2016-0166
Study First Received:	November 29, 2016
Last Updated:	December 4, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Citric Acid Ascorbic Acid Magnesium citrate Picosulfate sodium Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action	Antioxidants Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances Cathartics Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 17, 2017

To Top