Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation

Colonoscopy Clinical Trial

— PSPEG  

Official title:

Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513096
• Other study ID #: GI-201201
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2012
• Last updated: March 30, 2012
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.

Description:

This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.

Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient who are scheduled for colonoscopy

Exclusion Criteria:

• pregnancy,

• breast feeding,

• known or suspected bowel obstruction, and

• known allergy to PEG or Itopride ,

• presence of severe illness(renal failure, congestive heart failure, liver failure,), and

• refusal of consent to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Drug:
• itopride
itopride, 10mg, twice per day, for 1 day

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital, Inje University School of Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel cleaning quality according to Ottawa scale scores		3 months	No
Secondary	procedure time and polyp detection rate	cecal intubation time, polyp detection rate, degree of patient discomfort	3 months	No