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Simethicone and N-acetylcysteine in Upper Endoscopy - Prospective Double-blinded Randomized Controlled Trial

NCT02357303 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-01-08

No results posted yet for this study

Summary

The upper endoscopy is one of the most common methods for the diagnosis and treatment of upper gastrointestinal (GI) tract diseases and provides a unique opportunity to identify early neoplastic lesions.

Before an upper endoscopy it is required a 6 hour fasting period\[1\]. However, even with this fasting period, sometimes the mucosal visualization, especially in the stomach, is impaired by the presence of foam, bubbles or gastric mucus.

To improve visualization of the gastric mucosa, it is possible to administrate an oral solution of defoaming agents such as Simethicone and mucolytic agents like Pronase or N-Acetylcysteine previously to the procedure.

The aim of this project is to determine if the use of premedication with simethicone, alone or in association with N-Acetylcysteine, improves mucosal visualization during an upper GI endoscopy.

Conditions

  • Gastric Mucosal Lesion

Interventions

DRUG

Simethicone

100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy

DRUG

Acetylcysteine

100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy

OTHER

Placebo

100mL of water

Sponsors & Collaborators

  • Portuguese Oncology Institute, Coimbra

    lead OTHER

Principal Investigators

  • Luís Elvas, MD · Gastroenterology Department, Portuguese Oncology Institute - Coimbra

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02357303 on ClinicalTrials.gov