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

Phase 2

Completed

• Conditions: Bowel Preparation; Sodium Picosulfate and Magnesium Citrate; Polyethylene Glycol With Ascorbic Acid
• Interventions: Drug: sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid

• Registration Number: NCT02979223
• Lead Sponsor: National Cancer Center, Korea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-01
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score)	during colonoscopy

Trial Locations

Locations (1)

Bun Kim; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of