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NCT05951712: SIMETHICONE

Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy

Completed NA Last updated 24 July 2023
What this trial tests

NA trial testing Simethicone 150mg in Mucosal Erosion in 800 participants. Completed in 4 November 2022.

Timeline
16 June 2022
Primary endpoint
20 August 2022
4 November 2022

Quick facts

Lead sponsorAsian Institute of Gastroenterology, India
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposediagnostic
Enrollment800
Start date16 June 2022
Primary completion20 August 2022
Estimated completion4 November 2022
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Asian Institute of Gastroenterology, India

Who can join

Adults 18 to 80, any sex, with Mucosal Erosion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, we aimed to compare combined premedication with simethicone or N-acetylcysteine (NAC) for mucosal visualisation during esophagogastroduodenoscopy (EGD). The primary outcome of the study was comparison of total mucosal visibility score (TMVS) between combined pre-medication (Simethicone+ NAC) and individual pre-medication groups (Simethicone and NAC) in patients undergoing EGD. Secondary outcomes included comparison of TMVS between different groups, TMVS in early (10-20 min) versus late (\>20-30 min) endoscopy groups, adequate gastric mucosal visibility, detection of lesions and adverse events related to the pre-medications. Adequate and inadequate gastric mucosal visibility was defined as a cumulative score of \<7 and ≥7, respectively.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial.
    Nabi Z, Vamsi M, Goud R, Sayyed M, et al · · 2024 · cited 6× · PMID 37848768 · DOI 10.1007/s12664-023-01459-0

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