NCT01685970

Brief Summary

Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG. The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

September 17, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

September 12, 2012

Last Update Submit

September 14, 2012

Conditions

Colonoscopy

Keywords

Bowel preparationcolonoscopypolyethylene glycolpicosulfate

Outcome Measures

Primary Outcomes (1)

  • Quality of bowel preparation

    Quality of bowel preparation using Ottawa bowel preparation scale

    3 months

Secondary Outcomes (1)

  • Tolerability

    3 months

Study Arms (2)

High volume Split-dose PEG

PLACEBO COMPARATOR

Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation

Drug: High volume split-dose PEG

2 sachets of picosulfate

ACTIVE COMPARATOR

Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.

Drug: 2 sachets of picosulfate

Interventions

High volume split-dose PEGDRUG

High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy

Also known as: Polyethylene glycol(Colyte)
High volume Split-dose PEG
2 sachets of picosulfateDRUG

2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy

Also known as: sodium picosulfate
2 sachets of picosulfate

Eligibility Criteria

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

You may qualify if:

  • Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms

You may not qualify if:

  • pregnancy,
  • breast feeding,
  • prior history of surgical large bowel resection,
  • severe medical condition such as severe cardiac,
  • hepatic, or
  • renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
  • significant gastric paresis or gastric outlet obstruction or ileus,
  • known or suspected bowel obstruction or perforation,
  • drug addiction or major psychiatric illness,
  • allergy to PEG and refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae Paik Hospital, Inje University College of Medicine

Busan, 612-030, South Korea

RECRUITING

MeSH Terms

Interventions

picosulfate sodium

Study Officials

  • Tae Oh Kim, Ph D

    Haeundae Paik Hospital, Inje University College of Medicine

    STUDY DIRECTOR

Central Study Contacts

Tae Oh Kim, Ph D.

CONTACT

82-51-797-0658kto0440@paik.ac.kr

Eun Hee Seo, MD

CONTACT

82-51-797-0220arate98@naver.com

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
Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for aternoon colonoscopy

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 17, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 17, 2012

Record last verified: 2012-09

Locations

KR(1)