Clinical trial · Interventional
Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy
Effectiveness of Premedication With Simethicone or Simethicone Plus N-acetylcysteine vs. Placebo in Improving Visibility During Upper Endoscopy.
NCT01653171CI-TRIAL-00032451PRUEcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy compared with use of water or no preparation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N-acetylcysteine 1000 mg | Drug | — | UNRESOLVED |
| N-acetylcysteine 500 mg | Drug | — | UNRESOLVED |
| Simethicone | Drug | — | UNRESOLVED |
| Water (Placebo) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard upper endoscopy withouth premedication
- type
- PLACEBO_COMPARATOR
- label
- Water
- description
- 100 mL of water, 20 minutes before upper endoscopy
- interventionNames
- Drug: Water (Placebo)
- type
- EXPERIMENTAL
- label
- Simethicone
- description
- Simethicone 200 mg, in water for up to 100 mL, to take 20 minutes prior to examination
- interventionNames
- Drug: Simethicone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnostic upper endoscopy performed for medical indications Exclusion Criteria: * Upper gastrointestinal surgery * Gastric Cancer * Deep sedation with propofol * Indication of therapeutic endoscopy * Emergency endoscopy * Patients with a history of * Upper gastrointestinal bleeding * Caustic ingestion * Pregnancy * Diabetes mellitus * Asthma * Allergic reactions to medication
References
Publications (20)
- RESULTLambert R, Guilloux A, Oshima A, Pompe-Kirn V, Bray F, Parkin M, Ajiki W, Tsukuma H. Incidence and mortality from stomach cancer in Japan, Slovenia and the USA. Int J Cancer. 2002 Feb 20;97(6):811-8. doi: 10.1002/ijc.10150. PMID 11857360
- RESULTCsendes A, Smok G, Medina E, Salgado I, Rivera R, Quitral M. [Clinical course characteristics of gastric cancer 1958-1990]. Rev Med Chil. 1992 Jan;120(1):36-42. Spanish. PMID 1305308
- RESULTMcColl KE. Screening for early gastric cancer. Gut. 2005 Jun;54(6):740-2. doi: 10.1136/gut.2004.058461. No abstract available. PMID 15888773
- RESULTTashiro A, Sano M, Kinameri K, Fujita K, Takeuchi Y. Comparing mass screening techniques for gastric cancer in Japan. World J Gastroenterol. 2006 Aug 14;12(30):4873-4. doi: 10.3748/wjg.v12.i30.4873. PMID 16937471
- RESULTEverett SM, Axon AT. Early gastric cancer: disease or pseudo-disease? Lancet. 1998 May 2;351(9112):1350-2. doi: 10.1016/s0140-6736(98)04365-7. No abstract available. PMID 9643813
- RESULTOno H, Kondo H, Gotoda T, Shirao K, Yamaguchi H, Saito D, Hosokawa K, Shimoda T, Yoshida S. Endoscopic mucosal resection for treatment of early gastric cancer. Gut. 2001 Feb;48(2):225-9. doi: 10.1136/gut.48.2.225. PMID 11156645
- RESULTChavez Rossell M. [Endoscopic treatment of early gastric cancer: from Endoscopic Mucosal Resection (EMR) to Endoscopic Submucosal Dissection (ESD)]. Rev Gastroenterol Peru. 2005 Jan-Mar;25(1):76-92. Spanish. PMID 15818423
- RESULTFederation nationale des centres de lutte contre le cancer. [Recommendations for clinical practice: 2004 Standards, Options and Recommendations for management of patients with adenocarcinomas of the stomach (excluding cardial and other histological forms of cancer) Federation nationale des centres de lutte contre le cancer]. Gastroenterol Clin Biol. 2005 Jan;29(1):41-55. doi: 10.1016/s0399-8320(05)80692-x. No abstract available. French.