CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
omeprazoledrug
Likely dose
omeprazole 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01389401
NCT01389401N/ACompleted

Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis: Final Results

Faculdade de Ciências Médicas da Santa Casa de São Paulo·observational·Posted Jul 8, 2011·Updated Mar 6, 2013

In Brief

An observational study evaluating omeprazole for Gastroesophageal Reflux Disease (GERD) and Chronic Laryngitis. Completed, enrolled 36 participants across 1 site.

Detailed Summary

* Saliva plays a key role in the homeostasis of the digestive tract * The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal and pharyngeal mucosas * There seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes, suggesting individual protective mechanisms to refluxate exposure * Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis (Laryngopharyngeal Reflux- LPR) * Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in patients with GERD and LPR, but it is unclear if these are primary or secondary to the disease. * Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2011
Enrollment StartJan 1, 2009
Primary CompletionJan 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.0 years ago

Interventions

omeprazoledrug

omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes