Usefulness Of Flospan As A Premedication For Colonoscopy

Colonoscopy Clinical Trial

Official title:

Usefulness Of Flospan As A Premedication For Colonoscopy : A Randomized Double Blind Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01842932
• Other study ID #: AJIRB-MED-CT4-09-257
• Status: Recruiting
• Phase: Phase 4
• First received: April 14, 2013
• Last updated: June 25, 2014
• Start date: December 2009
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Ajou University School of Medicine
• Contact: Kee Myung Lee, M.D., Ph.D.
• Phone: 82-31-219-6939
• Email: lkm5104[@]ajou.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind controlled trial

Description:

Cimetropium bromide is premedication of colonoscopy. However, it is contraindication for some diseases; benign prostatic hyperplasia(BPH) or other obstructive uropathy, intestinal obstruction, pyloric stenosis, glaucoma, myasthenia gravis, megacolon, paralytic ileus. In this cases, Flospan (phloroglucin) is effective alternative drug. So our research was to compare the effects of these two drugs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recipient endoscopic diagnostic purposes.

Exclusion Criteria:

• If you currently pregnant, or of childbearing potential

• Previous abdominal surgery or bowel resection.

• If under 18 years of age

• If the last two days, the administration of anticholinergic

Study Design

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Phloroglucin
Premedication of colonoscopy
• Cimetropium bromide
Premedication of colonoscopy

Procedure:
• Colonoscopy
Diagnostic examination of colon

Drug:
• Placebo
Placebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bowel cleansing status		1 year	No
Other	Heart rate, respiratory rate, oxygen saturation, blood pressure		1 year	No
Primary	Non inferiority of phloroglucin to cimetropium bromide	Comparing the two groups of time of examination, frequency of peristalsis, Scoring for the experimenter and the subject of the inspection feedback, double-blind setting.	Up to ten months	No
Secondary	Total diagnostic colonoscopy exam time		1 year	No
Secondary	Evaluation of practitioners	Colonic motility and test difficulty	1 year	No
Secondary	Evaluation of subjects	The degree of discomfort after test	1 year	No
Secondary	Peristalsis time of transverse colon	Total peristalsis time of transverse colon for two minutes	1 year	No
Secondary	Total dose and times of sedatives for pain control	Total dose and times of sedatives (midazolam, propofol) for pain control	1 year	No
Secondary	Time of cecal intubation	Total time of colonoscope intubation from anus to cecum	1 year	No