NCT03342118

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

August 16, 2017

Last Update Submit

December 29, 2017

Conditions

Anti-spasmodicsGastric PeristalsisNon-sedative Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Peristasis changes from baseline at the moment of endoscopy

    Modified peristalsis grade (No, weak, moderate, severe, very severe)

    1day

Secondary Outcomes (2)

  • Discomfort of endoscopy

    1day

  • Taste of the drug

    1day

Study Arms (2)

Phloroglucin group

EXPERIMENTAL

patients taken Phloroglucin(Flospan®)

Drug: Phloroglucin(Flospan®)

Normal saline placebo group

PLACEBO COMPARATOR

patients taken normal saline placebo

Drug: Normal saline

Interventions

Phloroglucin(Flospan®)DRUG

The experimental group was taken with Phloroglucin(Flospan®) before endoscopy.

Phloroglucin group
Normal salineDRUG

The control group was treated with normal saline before endoscopy

Normal saline placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KeimyungUniversity

Daegu, Jung-gu, 700-712, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34347808DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2017

First Posted

November 14, 2017

Study Start

September 21, 2017

Primary Completion

December 29, 2017

Study Completion

December 29, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

KR(1)