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Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03849196
Collaborator
(none)
168
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
27.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.

Condition or Disease Intervention/Treatment Phase
  • Drug: 2L PEG-Asc
  • Drug: Bisacodyl 10Mg Suppository
  • Drug: 1L PEG-Asc
 N/A

Detailed Description

Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.

Outcome measures: the Boston Bowel Preparation Scale (BBPS)

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective, randomized, and observer-blind studyprospective, randomized, and observer-blind study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Simultaneous Combination of Bisacodyl Suppository Agent and 1L Polyethylene Glycol Plus Ascorbic Acid is Not Inferior and Comfortable Regimen Compared With 2L Polyethylene Glycol Plus Ascorbic Acid: A Randomized Controlled Study
Actual Study Start Date :
Jul 31, 2017
Actual Primary Completion Date :
Jan 30, 2018
Actual Study Completion Date :
Jan 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2L PEG-Asc

2L PEG-Asc for bowel preparation

Drug: 2L PEG-Asc
PEG-Asc powder
Other Names:
  • clicool
  • coolprep

    		•
    Active Comparator: 1L PEG-Asc & 'Bisacodyl 10Mg Suppository

    1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation

    Drug: Bisacodyl 10Mg Suppository
    bisacodyl 10 mg suppository

    Drug: 1L PEG-Asc
    PEG-Asc powder
    Other Names:
  • clicool
  • coolprep

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Boston Bowel Preparation Scale (BBPS). [1 hour]

      4-point scoring system (0-3) applied to each of the 3 colon segments (right colon including cecum and ascending colon, transverse colon including transverse colon, hepatic and splenic flexure, left colon including descending colon, sigmoid colon, and rectum)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • outpatients who were scheduled for colonoscopy between August 2017 and January 2018
    Exclusion Criteria:

    • History of gastrointestinal tract surgery

    • History of inflammatory bowel disease

    • History of severe active colitis

    • History of chronic kidney disease

    • pregnant woman.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 06351

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: brian.biochem@gmail.com Kim, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eun Ran Kim, Clinical associate professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT03849196
    Other Study ID Numbers:
    • 2017-05-100
    First Posted:
    Feb 21, 2019
    Last Update Posted:
    Feb 21, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bisacodyl

    Study Results

    No Results Posted as of Feb 21, 2019