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NCT02979223 Clinical Trial

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

Bowel Preparation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02979223
Other study ID # NCC2016-0166
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2016
Est. completion date June 2017

Study information
Verified date August 2019
Source National Cancer Center, Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 142
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

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

Intervention

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

Locations
Country Name City State
Korea, Republic of Bun Kim Goyang Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score) during colonoscopy
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