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NCT05951712: SIMETHICONE
Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy
NA trial testing Simethicone 150mg in Mucosal Erosion in 800 participants. Completed in 4 November 2022.
20 August 2022
Quick facts
| Lead sponsor | Asian Institute of Gastroenterology, India |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | diagnostic |
| Enrollment | 800 |
| Start date | 16 June 2022 |
| Primary completion | 20 August 2022 |
| Estimated completion | 4 November 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- Simethicone 150mg — full drug profile →
- N Acetyl cysteine 600mg — full drug profile →
- Simethicone 150mg plus N Acetyl cysteine 600 mg — full drug profile →
- Placebo
Conditions studied
- Mucosal Erosion — all drugs for Mucosal Erosion →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05951712
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05951712 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asian Institute of Gastroenterology, India
- Last refreshed: 24 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05951712.
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