Lesion of StomachPhase 2/3NCT02555228
Small Volume Simethicone Before Gastroscopy: Any Benefit?
A Phase 2/3 study testing Simethicone and Water in people with Lesion of Stomach, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lesion of Stomach
- What is being tested?
- Simethicone and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2015to Nov 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- history of dysphagia
- known hypersensitivity to simethicone
- previous gastrectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study
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.
Read the detailed description
Excessive bubbles or foam during gastroscopy is a common problem which can cause significant hindrance to an optimal evaluation of the gastric mucosa, prolong the procedure time, and contribute to poor patient tolerance during the scope.
Simethicone, with or without N-acetylcysteine, has been extensively evaluated to improve mucosal visibility. However, the volume of simethicone preparation and the timing of ingesting this solution before gastroscope varied significantly across different studies. In general, it appeared that a larger volume of simethicone solution, given earlier before the gastroscopy, may yield better results. However, allowing a patient to ingest a large volume of liquid before a gastroscopy under sedation brings forth the risk of aspiration. A recent Taiwanese study published in 2014 [1] showed that the subgroup with 100mg of simethicone in just 5ml of water, did achieve a good total mucosal visibility score, if the solution was ingested more than 30 minutes before the gastroscope. This may be because a longer time allows the simethicone to coat more of the mucosa. However, this study did not compare this preparation against a placebo.
In Changi General Hospital, many gastroscopies are done daily with no premedication. Also, there is no protocol for premedication before gastroscopes. This study hopes to prove that a low volume of simethicone solution, given at an ample time (more than 30 minutes) before the scope, can significantly improve overall endoscopy performance compared to no premedication at all.
- Conditions
- Lesion of Stomach
- Being tested
- Simethicone, Water
- Keywords
- simethicone, gastroscopy, McNalley score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimethiconeDrug
100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
WaterOther
5mls of water is given at least 30 minutes before the gastroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Simethicone premedication | Experimental | Liquid simethicone (1ml volume) in 5mls of water Receives: Drug: Simethicone |
| Placebo | Placebo comparator | Just 5 mls of water Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
- Area E: esophagus
- Area D: duodenum
- Area A: antrum and angularis
- Area B: body and fundus
Mc Nally score per area:
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
Measured: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
Volume of Additional Manual Flushes Required During Endoscopy in Mls
The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.
Measured: 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
Measured: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lesion of StomachStudies 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555228
- Sponsor's protocol ID
- CGH-QIPSMJ
- Status last verified
- Feb 2016
- First submitted
- 13 Sep 2015
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data send to Singapore Health Sciences Authority
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Premedication With Small Volume Simethicone Solution Before Diagnostic Gastroscopy: A Randomized Endoscopist-blinded Prospective Study
- ClinicalTrials.gov ID
- NCT02555228
- Acronym / sponsor ID
- CGH-QIPSMJ
- Conditions
- Lesion of Stomach
- Keywords
- simethicone, gastroscopy, McNalley score
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Posted 15 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Excessive bubbles or foam during gastroscopy is a common problem which can cause significant hindrance to an optimal evaluation of the gastric mucosa, prolong the procedure time, and contribute to poor patient tolerance during the scope.
Simethicone, with or without N-acetylcysteine, has been extensively evaluated to improve mucosal visibility. However, the volume of simethicone preparation and the timing of ingesting this solution before gastroscope varied significantly across different studies. In general, it appeared that a larger volume of simethicone solution, given earlier before the gastroscopy, may yield better results. However, allowing a patient to ingest a large volume of liquid before a gastroscopy under sedation brings forth the risk of aspiration. A recent Taiwanese study published in 2014 [1] showed that the subgroup with 100mg of simethicone in just 5ml of water, did achieve a good total mucosal visibility score, if the solution was ingested more than 30 minutes before the gastroscope. This may be because a longer time allows the simethicone to coat more of the mucosa. However, this study did not compare this preparation against a placebo.
In Changi General Hospital, many gastroscopies are done daily with no premedication. Also, there is no protocol for premedication before gastroscopes. This study hopes to prove that a low volume of simethicone solution, given at an ample time (more than 30 minutes) before the scope, can significantly improve overall endoscopy performance compared to no premedication at all.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simethicone premedication | Experimental | Drug: SimethiconeLiquid simethicone (1ml volume) in 5mls of water |
| Placebo | Placebo comparator | Other: WaterJust 5 mls of water |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Simethicone100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy. | Drug | Simethicone premedication |
| Water5mls of water is given at least 30 minutes before the gastroscopy. | Other | Placebo |
Primary outcome
Total Cumulative Mucosal Visibility Score
Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
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
3 secondary outcomes
Mucosal Visibility Score Per Area as Determined by Mc Nally Score:
Time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.
Volume of Additional Manual Flushes Required During Endoscopy in Mls
Time frame: 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
Time frame: Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data send to Singapore Health Sciences Authority
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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.
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 2/3 study testing Simethicone and Water in people with Lesion of Stomach, run by Changi General Hospital at 1 site in Singapore.
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 9 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 15 Mar 2016. 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 Singapore. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Cumulative Mucosal Visibility Score (time frame: This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.). 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 15 Mar 2016.