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Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas

2014-07-24 14:19:42 | BioPortfolio

Summary

The purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg (Nexium) or placebo (inactive drug) on vocal cord granulomas.

Description

Vocal cord granulomas (VCG) are common structural lesions of vocal cords attributed to vocal abuse / misuse and recently to gastroesophageal reflux. Vocal process granulomas are reactive/reparative process, in which an intact or ulcerated squamous epithelium is underlaid by granulation tissue or fibrosis (4, 5). Ulualp et al (6) have reported a higher prevalence of pharyngeal acid reflux (PAR) events in patients with vocal cord lesions. In a case control study they showed that the prevalence of pharyngeal reflux, documented with 3 site pharyngoesophageal pH monitoring, is higher among patients with posterior laryngitis and vocal cord lesions than control (78% vs. 21%). Most recently our cohort trial in over 80 patients with laryngeal findings suggestive of GERD suggested that vocal cord abnormalities such as granulomas may be more specific sign of GERD than any other (7). Thus, there is reasonable scientific intrigue regarding this laryngeal finding and the causal role from gastroesophagopharyngeal acid reflux requiring better studies. However, no study has evaluated the potential causal association between GERD and VCGs.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Larynx Disease

Intervention

Esomeprazole

Location

Vanderbilt University Medical Center
Nashville
Tennessee
United States
37232

Status

Withdrawn

Source

Vanderbilt University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:42-0400

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Medical and Biotech [MESH] Definitions

The S-isomer of omeprazole.

The mucous lining of the LARYNX, consisting of various types of epithelial cells ranging from stratified squamous EPITHELIUM in the upper larynx to ciliated columnar epithelium in the rest of the larynx, mucous GOBLET CELLS, and glands containing both mucous and serous cells.

The bottom portion of the pharynx situated below the OROPHARYNX and posterior to the LARYNX. The hypopharynx communicates with the larynx through the laryngeal inlet, and is also called laryngopharynx.

Complete loss of phonation due to organic disease of the larynx or to nonorganic (i.e., psychogenic) causes.

Methods of enabling a patient without a larynx or with a non-functional larynx to produce voice or speech. The methods may be pneumatic or electronic.

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