NCT01528098

Brief Summary

The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

February 3, 2012

Last Update Submit

February 20, 2012

Conditions

Intestine; Complaints

Keywords

polyethylene glycolbisacodyl

Outcome Measures

Primary Outcomes (1)

  • The efficacy of bowel preparation

    Ottawa scale

    one day (after colonoscopy)

Secondary Outcomes (3)

  • Patient's compliance and acceptability

    one day (after injestion of preparation solution)

  • Patient's compliance and acceptability (2)

    one day (after injestion of preparation solution)

  • Patient's compliance and acceptability (3)

    one day (after colonoscopy)

Study Arms (2)

PEG plus bisacodyl

Those who taken PEG 4L + bisacodyl 10mg

PEG 4L

Those who taken PEG 4L alone

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients for colonoscopy in university hospital.

You may qualify if:

  • Hospitalized patients for colonoscopy

You may not qualify if:

  • age under 20 years or over 80 years
  • major psychiatric illness
  • known allergy to PEG
  • serious condition- severe cardiac, renal, or metabolic diseases
  • partial colon resection
  • current acute exacerbation of chronic inflammatory bowel disease
  • functional constipation defined by Rome III diagnostic criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Dong Il Park, Professor

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Il Park, professor

CONTACT

82-2-2001-2059diksmc.park@samsung.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Department of Internal Medicine

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 7, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02