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

NCT ID: NCT02979223

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Picosolution; Coolprep

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Byung Chang KIM

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bun Kim, Dr

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

Bun Kim

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC2016-0166

Identifier Type: -

Identifier Source: org_study_id