Usefulness Of Flospan As A Premedication For Colonoscopy

Phase 4

• Conditions: Colonoscopy
• Interventions: Drug: Phloroglucin; Drug: Cimetropium bromide; Procedure: Colonoscopy; Drug: Placebo

• Registration Number: NCT01842932
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-30
• Primary Completion: 2013-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-27
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phloroglucin & Placebo	Phloroglucin	Phloroglucin 20ml before examination \& Placebo 1ml before examination
Phloroglucin & Placebo	Colonoscopy	Phloroglucin 20ml before examination \& Placebo 1ml before examination
Phloroglucin & Placebo	Placebo	Phloroglucin 20ml before examination \& Placebo 1ml before examination
Cimetropium bromide & Placebo	Cimetropium bromide	Cimetropium bromide 1ml before examination \& Placebo 20ml before examination
Cimetropium bromide & Placebo	Colonoscopy	Cimetropium bromide 1ml before examination \& Placebo 20ml before examination
Cimetropium bromide & Placebo	Placebo	Cimetropium bromide 1ml before examination \& Placebo 20ml before examination

Primary Outcome Measures

Name	Time	Method
Non inferiority of phloroglucin to cimetropium bromide	Up to ten months	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.

Secondary Outcome Measures

Name	Time	Method
Total diagnostic colonoscopy exam time	1 year
Evaluation of practitioners	1 year	Colonic motility and test difficulty
Evaluation of subjects	1 year	The degree of discomfort after test
Peristalsis time of transverse colon	1 year	Total peristalsis time of transverse colon for two minutes
Total dose and times of sedatives for pain control	1 year	Total dose and times of sedatives (midazolam, propofol) for pain control
Time of cecal intubation	1 year	Total time of colonoscope intubation from anus to cecum

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of