ColonoscopyPhase 4NCT01842932
Usefulness Of Flospan As A Premedication For Colonoscopy
A Phase 4 study testing Phloroglucin, Cimetropium bromide and Colonoscopy in people with Colonoscopy, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Usefulness of Flospan as a premedication for colonoscopy: A randomized double-blind controlled trial Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Phloroglucin, Cimetropium bromide and Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recipient endoscopic diagnostic purposes.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Suwon, 443-721
Kee Myung Lee, M.D., Ph.D., 82-31-219-6939, lkm5104@ajou.ac.kr
Sun Gyo Lim, M.D., 82-31-219-6939, mdlsk75@hanmail.net
About this study
Official title: 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
Read the 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.
- Conditions
- Colonoscopy
- Being tested
- Phloroglucin, Cimetropium bromide, Colonoscopy, Placebo
- Keywords
- Colonoscopy, Anticholinergics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhloroglucinDrug
Also called Flospan
Premedication of colonoscopy
Cimetropium bromideDrug
Also called Anticholinergics, Algiron
Premedication of colonoscopy
ColonoscopyProcedure or surgery
Also called Diagnostic examination of colon
Diagnostic examination of colon
PlaceboDrug
Placebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Phloroglucin & Placebo | Experimental | Phloroglucin 20ml before examination \& Placebo 1ml before examination Receives: Drug: Phloroglucin; Procedure: Colonoscopy; Drug: Placebo |
| Cimetropium bromide & Placebo | Experimental | Cimetropium bromide 1ml before examination \& Placebo 20ml before examination Receives: Drug: Cimetropium bromide; Procedure: Colonoscopy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to ten months
Secondary outcomes (6)
Total diagnostic colonoscopy exam time
Measured: 1 year
Evaluation of practitioners
Colonic motility and test difficulty
Measured: 1 year
Evaluation of subjects
The degree of discomfort after test
Measured: 1 year
Peristalsis time of transverse colon
Total peristalsis time of transverse colon for two minutes
Measured: 1 year
Total dose and times of sedatives for pain control
Total dose and times of sedatives (midazolam, propofol) for pain control
Measured: 1 year
Time of cecal intubation
Total time of colonoscope intubation from anus to cecum
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startDec 2009
- Primary completionDec 2013
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Gyo Lim, Ajou University School of Medicine
- Investigators
- Kee Myung Lee, M.D., Ph.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842932
- Sponsor's protocol ID
- AJIRB-MED-CT4-09-257
- Status last verified
- Jun 2014
- First submitted
- 14 Apr 2013
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness Of Flospan As A Premedication For Colonoscopy : A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01842932
- Acronym / sponsor ID
- AJIRB-MED-CT4-09-257
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy, Anticholinergics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phloroglucin & Placebo | Experimental | Drug: Phloroglucin, Procedure: Colonoscopy, Drug: PlaceboPhloroglucin 20ml before examination \& Placebo 1ml before examination |
| Cimetropium bromide & Placebo | Experimental | Drug: Cimetropium bromide, Procedure: Colonoscopy, Drug: PlaceboCimetropium bromide 1ml before examination \& Placebo 20ml before examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recipient endoscopic diagnostic purposes.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhloroglucinAlso: FlospanPremedication of colonoscopy | Drug | Phloroglucin & Placebo |
| Cimetropium bromideAlso: Anticholinergics, AlgironPremedication of colonoscopy | Drug | Cimetropium bromide & Placebo |
| ColonoscopyAlso: Diagnostic examination of colonDiagnostic examination of colon | Procedure or surgery | Cimetropium bromide & Placebo, Phloroglucin & Placebo |
| PlaceboPlacebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy. | Drug | Cimetropium bromide & Placebo, Phloroglucin & Placebo |
Primary outcome
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.
6 secondary outcomes
Total diagnostic colonoscopy exam time
Time frame: 1 year
Evaluation of practitioners
Time frame: 1 year
Evaluation of subjects
Time frame: 1 year
Peristalsis time of transverse colon
Time frame: 1 year
Total dose and times of sedatives for pain control
Time frame: 1 year
Time of cecal intubation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kee Myung Lee, M.D., Ph.D. principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phloroglucin, Cimetropium bromide and Colonoscopy in people with Colonoscopy, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kee Myung Lee, M.D., Ph.D. (82-31-219-6939, lkm5104@ajou.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non inferiority of phloroglucin to cimetropium bromide (time frame: Up to ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.