Anti-spasmodicsPhase 3NCT03342118
Effect of Oral Phloroglucin (Flospan®) as Premedication of Non-sedative Diagnostic Esophagogastroduodenoscopy
A Phase 3 study testing Phloroglucin(Flospan®) and Normal saline in people with Anti-spasmodics and Gastric Peristalsis, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Gastric peristalsis, which occurs during the endoscopic procedure, limits the visual inspection of the inspection field, causing interference in the inspection. The actual endoscopic examination is most commonly used by injecting Hyoscine butylbromide(Buscopan®), Cimetropium bromide (Algiron ®) into intravenous or… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anti-spasmodics, Gastric Peristalsis, Non-sedative Endoscopy
- What is being tested?
- Phloroglucin(Flospan®) and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2017to 29 Dec 2017
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who perform non-sedative endoscopy for diagnosis or screening purposes.
- patients who understand and follow the directions and questionnaires of clinical trials.
- patients who have decided to voluntarily participate in this clinical trial and have agreed in writing
Who cannot join
- Patients who performed Upper GI surgery.
- Severe gastric outlet obstruction or malformations or gastroparesis
- Patients who have severe cognitive impairment
- Pregnant or lactation patients
- Patients who need to hemostasis for upper GI bleeding
- Hemodynamic unstable patients
- Above American Society of Anesthesiology classification class 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Phloroglucin (Flospan®) as Premedication of Non-sedative Diagnostic Esophagogastroduodenoscopy: Single Center, Prospective, Double Blinded, Randomized Controlled Trial
Gastric peristalsis, which occurs during the endoscopic procedure, limits the visual inspection of the inspection field, causing interference in the inspection. The actual endoscopic examination is most commonly used by injecting Hyoscine butylbromide(Buscopan®), Cimetropium bromide (Algiron ®) into intravenous or muscular injection so it is not suitable for patients who undergo non-sedative esophagogastroduodenoscopy. In addition, these drugs were reported the side effects including thirst, dysuria, transient visual filed defect, tachycardia, anxiety so were not recommended for benign prostate hyperplasia, glaucoma, old age patients. For comfort and succesfull test, anti-spasmodics which don't have anti-cholinergic effect and are possible to take orally is necessary. Phloroglucin(Flospan®) is a smooth muscle relaxant that is currently used in the anti-spasmodic treatment without anticholinergic action so it can be administered in patients with glaucoma or BPH. Also it is suitable for endoscopic premedication due to transparent liquid component. Therefore, in this study, we would like to confirm the efficacy and safety of Phloroglucin (Flospan ®), which can be taken orally, as an pre-medication for non-sedative endoscopy.
Read the detailed description
Background : Endoscopy is currently widely regarded as the most important test in diagnosing stomach disorders, including stomach cancer. Gastric peristalsis, which occurs during the endoscopic procedure, limits the visual filed of the inspection, causing interference in the inspection. The actual endoscopic examination is most commonly used by injecting Hyoscine butylbromide(Buscopan®), Cimetropium bromide (Algiron ®) into intravenous or muscular injection so it is not suitable for patients who undergo non-sedative endoscopy because intravenous assessment is unnecessary. In addition, these drugs were reported the side effects including thirst, dysuria, transient visual filed defect, tachycardia, anxiety so were not recommended for patients with benign prostatic hyperplasia, glaucoma, old age. Actually patients who undergo non-sedative endoscopy are used to perform examinations without using anti-spasmodics. In this case, gastric peristalsis restricts endoscopist's visibility and making accurate observation and prolonged inspection time increases patient's discomfort. For comfort and successfull test, anti-spasmodics which don't have anti-cholinergic effect and are possible to take orally is necessary. Phloroglucin(Flospan®) prompts to release norepinephrine by impeding catecholamine O-methyl transferase enzymes in visceral smooth muscle, so it works to control spasm by normalizing smooth muscle movement which was accelerated by acetylcholine. Phloroglucin(Flospan®) is a smooth muscle relaxant that is currently used in the anti-spasmodic treatment without anticholinergic action so it can be administered in patients with glaucoma or BPH. Also it is suitable for endoscopic premedication due to transparent liquid component. Therefore, in this study, we would like to confirm the efficacy and safety of Phloroglucin (Flospan ®), which can be taken orally, as an pre-medication for non-sedative endoscopy.
Aim : Analysis for the effects of Phloroglucin (Flospan ®) as pre-medication for non-sedative endoscopy
Material and methods : This study is a single center, prospective, double blinded, randomized controlled trial that will be performed in Keimyung University Dongsan medical center. A total of 134 patients aged 18 to 80 are enrolled and patients were randomly assigned to the test group and the placebo group, taking the test drug or placebo 10 minutes before the endoscopy. The endoscopist records the degree of peristaltic movement and the degree of difficulty of the test at the start and end of the test. The degree of the peristalsis and the discomfort of the examination are evaluated by the scale used in the previous study. The questionnaire will be used to evaluate the patient's discomfort after drug administration, the taste of the drug, and the intention to re-use the drug.
- Conditions
- Anti-spasmodics, Gastric Peristalsis, Non-sedative Endoscopy
- Being tested
- Phloroglucin(Flospan®), Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phloroglucin(Flospan®)Drug
The experimental group was taken with Phloroglucin(Flospan®) before endoscopy.
Normal salineDrug
The control group was treated with normal saline before endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Phloroglucin group | Experimental | patients taken Phloroglucin(Flospan®) Receives: Drug: Phloroglucin(Flospan®) |
| Normal saline placebo group | Placebo comparator | patients taken normal saline placebo Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peristasis changes from baseline at the moment of endoscopy
Modified peristalsis grade (No, weak, moderate, severe, very severe)
Measured: 1day
Secondary outcomes (2)
Discomfort of endoscopy
Simplified discomfort grade questionnaire (Very easy, easy, so so, difficult)
Measured: 1day
Taste of the drug
Taste grade (Poor, bad, so so, good, very good)
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start21 Sep 2017
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-spasmodicsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YooJin Lee, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342118
- Sponsor's protocol ID
- 2017-06-043
- Status last verified
- Dec 2017
- First submitted
- 16 Aug 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jung H, Kim HJ, Choi ES, Lee JY, Park KS, Cho KB, Lee YJ. Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial. PLoS One. 2021 Aug 4;16(8):e0255016. doi: 10.1371/journal.pone.0255016. eCollection 2021.
PubMed 34347808
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Phloroglucin (Flospan®) as Premedication of Non-sedative Diagnostic Esophagogastroduodenoscopy: Single Center, Prospective, Double Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03342118
- Acronym / sponsor ID
- 2017-06-043
- Conditions
- Anti-spasmodics, Gastric Peristalsis, Non-sedative Endoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 14 Nov 2017 (actual)
- 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.
Gastric peristalsis, which occurs during the endoscopic procedure, limits the visual inspection of the inspection field, causing interference in the inspection. The actual endoscopic examination is most commonly used by injecting Hyoscine butylbromide(Buscopan®), Cimetropium bromide (Algiron ®) into intravenous or muscular injection so it is not suitable for patients who undergo non-sedative esophagogastroduodenoscopy. In addition, these drugs were reported the side effects including thirst, dysuria, transient visual filed defect, tachycardia, anxiety so were not recommended for benign prostate hyperplasia, glaucoma, old age patients. For comfort and succesfull test, anti-spasmodics which don't have anti-cholinergic effect and are possible to take orally is necessary. Phloroglucin(Flospan®) is a smooth muscle relaxant that is currently used in the anti-spasmodic treatment without anticholinergic action so it can be administered in patients with glaucoma or BPH. Also it is suitable for endoscopic premedication due to transparent liquid component. Therefore, in this study, we would like to confirm the efficacy and safety of Phloroglucin (Flospan ®), which can be taken orally, as an pre-medication for non-sedative endoscopy.
Detailed description
Background : Endoscopy is currently widely regarded as the most important test in diagnosing stomach disorders, including stomach cancer. Gastric peristalsis, which occurs during the endoscopic procedure, limits the visual filed of the inspection, causing interference in the inspection. The actual endoscopic examination is most commonly used by injecting Hyoscine butylbromide(Buscopan®), Cimetropium bromide (Algiron ®) into intravenous or muscular injection so it is not suitable for patients who undergo non-sedative endoscopy because intravenous assessment is unnecessary. In addition, these drugs were reported the side effects including thirst, dysuria, transient visual filed defect, tachycardia, anxiety so were not recommended for patients with benign prostatic hyperplasia, glaucoma, old age. Actually patients who undergo non-sedative endoscopy are used to perform examinations without using anti-spasmodics. In this case, gastric peristalsis restricts endoscopist's visibility and making accurate observation and prolonged inspection time increases patient's discomfort. For comfort and successfull test, anti-spasmodics which don't have anti-cholinergic effect and are possible to take orally is necessary. Phloroglucin(Flospan®) prompts to release norepinephrine by impeding catecholamine O-methyl transferase enzymes in visceral smooth muscle, so it works to control spasm by normalizing smooth muscle movement which was accelerated by acetylcholine. Phloroglucin(Flospan®) is a smooth muscle relaxant that is currently used in the anti-spasmodic treatment without anticholinergic action so it can be administered in patients with glaucoma or BPH. Also it is suitable for endoscopic premedication due to transparent liquid component. Therefore, in this study, we would like to confirm the efficacy and safety of Phloroglucin (Flospan ®), which can be taken orally, as an pre-medication for non-sedative endoscopy.
Aim : Analysis for the effects of Phloroglucin (Flospan ®) as pre-medication for non-sedative endoscopy
Material and methods : This study is a single center, prospective, double blinded, randomized controlled trial that will be performed in Keimyung University Dongsan medical center. A total of 134 patients aged 18 to 80 are enrolled and patients were randomly assigned to the test group and the placebo group, taking the test drug or placebo 10 minutes before the endoscopy. The endoscopist records the degree of peristaltic movement and the degree of difficulty of the test at the start and end of the test. The degree of the peristalsis and the discomfort of the examination are evaluated by the scale used in the previous study. The questionnaire will be used to evaluate the patient's discomfort after drug administration, the taste of the drug, and the intention to re-use the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phloroglucin group | Experimental | Drug: Phloroglucin(Flospan®)patients taken Phloroglucin(Flospan®) |
| Normal saline placebo group | Placebo comparator | Drug: Normal salinepatients taken normal saline placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who perform non-sedative endoscopy for diagnosis or screening purposes.
- patients who understand and follow the directions and questionnaires of clinical trials.
- patients who have decided to voluntarily participate in this clinical trial and have agreed in writing
Key exclusion criteria (7 listed)
- Patients who performed Upper GI surgery.
- Severe gastric outlet obstruction or malformations or gastroparesis
- Patients who have severe cognitive impairment
- Pregnant or lactation patients
- Patients who need to hemostasis for upper GI bleeding
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 |
|---|---|---|
| Phloroglucin(Flospan®)The experimental group was taken with Phloroglucin(Flospan®) before endoscopy. | Drug | Phloroglucin group |
| Normal salineThe control group was treated with normal saline before endoscopy | Drug | Normal saline placebo group |
Primary outcome
Peristasis changes from baseline at the moment of endoscopy
Time frame: 1day
Modified peristalsis grade (No, weak, moderate, severe, very severe)
2 secondary outcomes
Discomfort of endoscopy
Time frame: 1day
Taste of the drug
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Derived from this study: PubMed 34347808Jung H, Kim HJ, Choi ES, Lee JY, Park KS, Cho KB, Lee YJ. Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial. PLoS One. 2021 Aug 4;16(8):e0255016. doi: 10.1371/journal.pone.0255016. eCollection 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phloroglucin(Flospan®) and Normal saline in people with Anti-spasmodics and Gastric Peristalsis, run by Keimyung University Dongsan Medical Center 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Jan 2018. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peristasis changes from baseline at the moment of endoscopy (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03342118, which also lists 1 linked publication.
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 3 Jan 2018.