NCT01513096

Brief Summary

In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
Last Updated

April 3, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

January 16, 2012

Last Update Submit

March 30, 2012

Conditions

ColonoscopyBowel Preparation

Keywords

colonoscopybowel preparationPEGProkinetics

Outcome Measures

Primary Outcomes (1)

  • bowel cleaning quality according to Ottawa scale scores

    3 months

Secondary Outcomes (1)

  • procedure time and polyp detection rate

    3 months

Study Arms (2)

Split-dose PEG

NO INTERVENTION

Bowel preparation using split dose PEG without prokinetics

Split dose PEG with prokinetics

ACTIVE COMPARATOR

Bowel preparation using split-dose PEG with prokinetics

Drug: itopride

Interventions

itoprideDRUG

itopride, 10mg, twice per day, for 1 day

Split dose PEG with prokinetics

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who are scheduled for colonoscopy

You may not qualify if:

  • pregnancy,
  • breast feeding,
  • known or suspected bowel obstruction, and
  • known allergy to PEG or Itopride ,
  • presence of severe illness(renal failure, congestive heart failure, liver failure,), and
  • refusal of consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae Paik Hospital, Inje University School of Medicine

Busan, 612-030, South Korea

Location

MeSH Terms

Interventions

itopride

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 3, 2012

Record last verified: 2012-01

Locations

KR(1)