NCT01568814

Brief Summary

Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
Last Updated

April 3, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

March 29, 2012

Last Update Submit

March 30, 2012

Conditions

Bowel PreparationColonoscopy

Keywords

colonoscopybowel preparationpolyethylene glycollow residue meal

Outcome Measures

Primary Outcomes (1)

  • Quality of bowel preparation

    Quality of bowel preparation is assessed using Ottawa bowel preparation scale.

    2 months

Secondary Outcomes (1)

  • Tolerability

    2 months

Study Arms (2)

High volume PEG

PLACEBO COMPARATOR

Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.

Drug: high volume PEG

Low volume PEG with low residual meals

ACTIVE COMPARATOR

Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation.

Drug: Low volume PEG

Interventions

Low volume PEGDRUG

low volume polyethylene glycol 2 liter one time

Low volume PEG with low residual meals
high volume PEGDRUG

high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times

High volume PEG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

You may not qualify if:

  • Age under 18 years
  • Pregnancy
  • Breast feeding
  • Prior history of surgical large bowel resection
  • Severe medical condition such as severe cardiac
  • Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
  • Drug addiction or major psychiatric illness
  • Suspected bowel obstruction or ileus
  • Allergy to PEG
  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 2, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 3, 2012

Record last verified: 2012-01

Locations

KR(1)