NCT01929668

Brief Summary

The purpose of this study is to compare preference of the patients, efficacy of preparation, and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid in patients with inactive ulcerative colitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

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

August 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

August 23, 2013

Last Update Submit

April 27, 2016

Conditions

Ulcerative Colitis

Keywords

ulcerative colitisbowel preparation

Outcome Measures

Primary Outcomes (1)

  • Number of patients who are willing to use the same preparation method for the next colonoscopy.

    day 1

Secondary Outcomes (1)

  • Number of patients who have ulcerative colitis symptom aggravation within 30 days after bowel preparation, measured by simple clinical colitis activity index (SCCAI).

    within 30 days after bowel preparation for colonoscopy

Study Arms (2)

polyethylene glycol

ACTIVE COMPARATOR

4L polyethylene glycol

Drug: polyethylene glycol

polyethylene glycol with ascorbic acid

EXPERIMENTAL

2L polyethylene glycol and ascorbic acid

Drug: polyethylene glycolDrug: Ascorbic Acid

Interventions

polyethylene glycolDRUG
polyethylene glycolpolyethylene glycol with ascorbic acid
Ascorbic AcidDRUG
polyethylene glycol with ascorbic acid

Eligibility Criteria

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

You may qualify if:

  • age \>18 years old
  • ulcerative colitis patients without symptoms for at least 1 year
  • ulcerative colitis patients who undergo colonoscopy for surveillance

You may not qualify if:

  • subjects who had abdominal surgery
  • pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Polyethylene GlycolsAscorbic Acid

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates

Study Officials

  • Eun Soo Kim, MD, PhD

    Keimyung University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

KR(1)