Usefulness Of Flospan As A Premedication For Colonoscopy

NCT ID: NCT01842932

Last Updated: 2014-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Phloroglucin & Placebo

Phloroglucin 20ml before examination \& Placebo 1ml before examination

Group Type EXPERIMENTAL

Phloroglucin

Intervention Type DRUG

Premedication of colonoscopy

Colonoscopy

Intervention Type PROCEDURE

Diagnostic examination of colon

Placebo

Intervention Type DRUG

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

Cimetropium bromide & Placebo

Cimetropium bromide 1ml before examination \& Placebo 20ml before examination

Group Type EXPERIMENTAL

Cimetropium bromide

Intervention Type DRUG

Premedication of colonoscopy

Colonoscopy

Intervention Type PROCEDURE

Diagnostic examination of colon

Placebo

Intervention Type DRUG

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

Interventions

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Phloroglucin

Premedication of colonoscopy

Intervention Type DRUG

Cimetropium bromide

Premedication of colonoscopy

Intervention Type DRUG

Colonoscopy

Diagnostic examination of colon

Intervention Type PROCEDURE

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Flospan Anticholinergics Algiron Diagnostic examination of colon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sun Gyo Lim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kee Myung Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

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Ajou University Hospital

Suwon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kee Myung Lee, M.D., Ph.D.

Role: CONTACT

82-31-219-6939

Sun Gyo Lim, M.D.

Role: CONTACT

82-31-219-6939

Facility Contacts

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Kee Myung Lee, M.D., Ph.D.

Role: primary

82-31-219-6939

Sun Gyo Lim, M.D.

Role: backup

82-31-219-6939

Other Identifiers

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AJIRB-MED-CT4-09-257

Identifier Type: -

Identifier Source: org_study_id

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