NCT01964417

Brief Summary

The purpose of this study is to compare the efficacy, acceptability and preparation-induced mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

September 30, 2013

Last Update Submit

January 9, 2014

Conditions

Colonoscopy

Keywords

BOWEL PREPARATIONPEGLow-volume PEG Plus Ascorbic Acid

Outcome Measures

Primary Outcomes (1)

  • Comparison of colon cleansing between the two solutions using Ottawa scale

    3month

Study Arms (2)

4L-split Dose of PEG Solution

ACTIVE COMPARATOR

4L-split Dose of PEG Solution for bowel preparation

Drug: Colonoscopy after bowel cleansing

Low-volume PEG Plus Ascorbic Acid

ACTIVE COMPARATOR

Low-volume PEG Plus Ascorbic Acid for bowel preparation

Drug: Colonoscopy after bowel cleansing

Interventions

Colonoscopy after bowel cleansingDRUG
4L-split Dose of PEG SolutionLow-volume PEG Plus Ascorbic Acid

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who want colonoscopy purposing screening among adults between the age of 20\~65

You may not qualify if:

  • Under the age of 20, older than 65, pregnant or lactating women, intestinal obstruction, structural intestinal disease, hypothyroidism, gastrointestinal motility, renal failure, congestive heart failure, liver failure, electrolyte abnormalities, who refused research informed consent, inflammatory bowel disease, the obvious symptoms of the disease in patients with lower gastrointestinal (bloody stools, diarrhea, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae Paik Hospital

Busan, 612-896, South Korea

Location

Study Officials

  • Jongha Park, MD

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 17, 2013

Study Start

September 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

KR(1)