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Usefulness Of Flospan As A Premedication For Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01842932
Recruitment Status : Unknown
Verified June 2014 by Sun Gyo Lim, Ajou University School of Medicine.
Recruitment status was:  Recruiting
First Posted : April 30, 2013
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Sun Gyo Lim, Ajou University School of Medicine

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

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Phloroglucin Drug: Cimetropium bromide Procedure: Colonoscopy Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Usefulness Of Flospan As A Premedication For Colonoscopy : A Randomized Double Blind Controlled Trial
Study Start Date : December 2009
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Phloroglucin & Placebo
Phloroglucin 20ml before examination & Placebo 1ml before examination
Drug: Phloroglucin
Premedication of colonoscopy
Other Name: Flospan

Procedure: Colonoscopy
Diagnostic examination of colon
Other Name: 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
Drug: Cimetropium bromide
Premedication of colonoscopy
Other Names:
  • Anticholinergics
  • Algiron

Procedure: Colonoscopy
Diagnostic examination of colon
Other Name: 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.




Primary Outcome Measures :
  1. Non inferiority of phloroglucin to cimetropium bromide [ Time Frame: 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 :
  1. Total diagnostic colonoscopy exam time [ Time Frame: 1 year ]
  2. Evaluation of practitioners [ Time Frame: 1 year ]
    Colonic motility and test difficulty

  3. Evaluation of subjects [ Time Frame: 1 year ]
    The degree of discomfort after test

  4. Peristalsis time of transverse colon [ Time Frame: 1 year ]
    Total peristalsis time of transverse colon for two minutes

  5. Total dose and times of sedatives for pain control [ Time Frame: 1 year ]
    Total dose and times of sedatives (midazolam, propofol) for pain control

  6. Time of cecal intubation [ Time Frame: 1 year ]
    Total time of colonoscope intubation from anus to cecum


Other Outcome Measures:
  1. Bowel cleansing status [ Time Frame: 1 year ]
  2. Heart rate, respiratory rate, oxygen saturation, blood pressure [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842932


Contacts
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Contact: Kee Myung Lee, M.D., Ph.D. 82-31-219-6939 lkm5104@ajou.ac.kr
Contact: Sun Gyo Lim, M.D. 82-31-219-6939 mdlsk75@hanmail.net

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 443-721
Contact: Kee Myung Lee, M.D., Ph.D.    82-31-219-6939    lkm5104@ajou.ac.kr   
Contact: Sun Gyo Lim, M.D.    82-31-219-6939    mdlsk75@hanmail.net   
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Kee Myung Lee, M.D., Ph.D. Ajou University School of Medicine
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Responsible Party: Sun Gyo Lim, Assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01842932    
Other Study ID Numbers: AJIRB-MED-CT4-09-257
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014
Keywords provided by Sun Gyo Lim, Ajou University School of Medicine:
Colonoscopy
Anticholinergics
Additional relevant MeSH terms:
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Bromides
Cholinergic Antagonists
Cimetropium
Anticonvulsants
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents