Usefulness Of Flospan As A Premedication For Colonoscopy

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

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

Study Overview

• Status: Unknown
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Phloroglucin; Procedure: Colonoscopy; Drug: Placebo; Drug: Cimetropium bromide

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 Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 443-721
    • Recruiting
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Phloroglucin & Placebo; Phloroglucin 20ml before examination & Placebo 1ml before examination	Drug: Phloroglucin; Premedication of colonoscopy; Other Names: Flospan; Procedure: Colonoscopy; Diagnostic examination of colon; Other Names: 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.
EXPERIMENTAL: Cimetropium bromide & Placebo; Cimetropium bromide 1ml before examination & Placebo 20ml before examination	Procedure: Colonoscopy; Diagnostic examination of colon; Other Names: 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.; Drug: Cimetropium bromide; Premedication of colonoscopy; Other Names: Anticholinergics; Algiron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Bowel cleansing status	1 year
Heart rate, respiratory rate, oxygen saturation, blood pressure	1 year

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Kee Myung Lee, M.D., Ph.D., Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: April 14, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (ESTIMATE): April 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Colonoscopy; Anticholinergics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Anticonvulsants; Bromides; Cholinergic Antagonists; Cimetropium
• Other Study ID Numbers: AJIRB-MED-CT4-09-257