Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy (SP2HP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Inje University
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, MD, Inje University
ClinicalTrials.gov Identifier:
NCT01685970
First received: September 12, 2012
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Drug: High volume split-dose PEG
Drug: 2 sachets of picosulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Quality of bowel preparation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Quality of bowel preparation using Ottawa bowel preparation scale


Secondary Outcome Measures:
  • Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Tolerability of bowel preparation regimen is assessed by patient questionnaire.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: High volume Split-dose PEG
Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation
Drug: High volume split-dose PEG
High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
Other Name: Polyethylene glycol(Colyte)
Active Comparator: 2 sachets of picosulfate
Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy.
Drug: 2 sachets of picosulfate
2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy
Other Name: sodium picosulfate

Detailed Description:

Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685970

Contacts
Contact: Tae Oh Kim, Ph D. 82-51-797-0658 ext 0658 kto0440@paik.ac.kr
Contact: Eun Hee Seo, MD 82-51-797-0220 ext 0220 arate98@naver.com

Locations
Korea, Republic of
Haeundae Paik Hospital, Inje University College of Medicine Recruiting
Busan, Korea, Republic of, 612-030
Contact: Eun Hee Seo, MD    82-51-797-0220 ext 0220    arate98@naver.com   
Contact: Tae Oh Kim, Ph D    52-51-797-0658 ext 0658    kto0440@paik.ac.kr   
Principal Investigator: Eun Hee Seo, MD         
Sponsors and Collaborators
Inje University
Investigators
Study Director: Tae Oh Kim, Ph D Haeundae Paik Hospital, Inje University College of Medicine
  More Information

No publications provided

Responsible Party: Eun Hee Seo, MD, Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for aternoon colonoscopy, Inje University
ClinicalTrials.gov Identifier: NCT01685970     History of Changes
Other Study ID Numbers: HGI-2012-09
Study First Received: September 12, 2012
Last Updated: September 14, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
Bowel preparation
colonoscopy
polyethylene glycol
picosulfate

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014