NCT01842932

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

4 years

First QC Date

April 14, 2013

Last Update Submit

June 25, 2014

Conditions

Colonoscopy

Keywords

ColonoscopyAnticholinergics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Total diagnostic colonoscopy exam time

    1 year

  • Evaluation of practitioners

    1 year

  • Evaluation of subjects

    1 year

  • Peristalsis time of transverse colon

    1 year

  • Total dose and times of sedatives for pain control

    1 year

  • +1 more secondary outcomes

Other Outcomes (2)

  • Bowel cleansing status

    1 year

  • Heart rate, respiratory rate, oxygen saturation, blood pressure

    1 year

Study Arms (2)

Phloroglucin & Placebo

EXPERIMENTAL

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

Drug: PhloroglucinProcedure: ColonoscopyDrug: Placebo

Cimetropium bromide & Placebo

EXPERIMENTAL

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

Drug: Cimetropium bromideProcedure: ColonoscopyDrug: Placebo

Interventions

PhloroglucinDRUG

Premedication of colonoscopy

Also known as: Flospan
Phloroglucin & Placebo
Cimetropium bromideDRUG

Premedication of colonoscopy

Also known as: Anticholinergics, Algiron
Cimetropium bromide & Placebo
ColonoscopyPROCEDURE

Diagnostic examination of colon

Also known as: Diagnostic examination of colon
Cimetropium bromide & PlaceboPhloroglucin & Placebo
PlaceboDRUG

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

Cimetropium bromide & PlaceboPhloroglucin & Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipient endoscopic diagnostic purposes.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, 443-721, South Korea

RECRUITING

MeSH Terms

Interventions

PhloroglucinolcimetropiumCholinergic AntagonistsColonoscopy

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCholinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Kee Myung Lee, M.D., Ph.D.

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82-31-219-6939lkm5104@ajou.ac.kr

Sun Gyo Lim, M.D.

CONTACT

82-31-219-6939mdlsk75@hanmail.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 14, 2013

First Posted

April 30, 2013

Study Start

December 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations

KR(1)