NCT02555228

Brief Summary

A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 15, 2016

Completed
Last Updated

March 15, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

September 13, 2015

Results QC Date

February 15, 2016

Last Update Submit

February 15, 2016

Conditions

Lesion of Stomach

Keywords

simethiconegastroscopyMcNalley score

Outcome Measures

Primary Outcomes (1)

  • Total Cumulative Mucosal Visibility Score

    Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score: Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured Total areas covered: (E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus

    This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

Secondary Outcomes (3)

  • Mucosal Visibility Score Per Area as Determined by Mc Nally Score:

    This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

  • Volume of Additional Manual Flushes Required During Endoscopy in Mls

    This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.

  • Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution

    Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours

Study Arms (2)

Simethicone premedication

EXPERIMENTAL

Liquid simethicone (1ml volume) in 5mls of water

Drug: Simethicone

Placebo

PLACEBO COMPARATOR

Just 5 mls of water

Other: Water

Interventions

SimethiconeDRUG

100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.

Simethicone premedication
WaterOTHER

5mls of water is given at least 30 minutes before the gastroscopy.

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned for an elective diagnostic gastroscopy by the attending gastroenterologist
  • Age of at least 21 years old
  • Mentally competent and able to provide informed consent

You may not qualify if:

  • Category A patients (incarcerated prisoners)
  • adults who are unable to give their own informed consent due to lack of mental capacity
  • suspected gastrointestinal bleeding
  • suspected impacted foreign material
  • suspected gastric outlet obstruction
  • suspected esophageal obstruction
  • history of dysphagia
  • known hypersensitivity to simethicone
  • previous gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Interventions

SimethiconeWater

Intervention Hierarchy (Ancestors)

DimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Results Point of Contact

Title
Dr Song Mingjun
Organization
MOHH Holdings
mingjun.song0950c@gmail.com
86337635

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 21, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 15, 2016

Results First Posted

March 15, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Data send to Singapore Health Sciences Authority

Locations

SG(1)