Phase 3
Completed N=54
Small Volume Simethicone Before Gastroscopy: Any Benefit?
Lesion of Stomach
Source: ClinicalTrials.gov NCT02555228 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Total Cumulative Mucosal Visibility Score — 5.78; 8.89 units
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cumulative Mucosal Visibility Score |
5.78; 8.89 | — |
| SECONDARY Mucosal Visibility Score Per Area as Determined by Mc Nally Score: |
1.48; 1.59; 1.26; 2.26; 1.30; 2.56 | — |
| SECONDARY Volume of Additional Manual Flushes Required During Endoscopy in Mls |
3.89; 84.81 | — |
| SECONDARY Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02555228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.