Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas

Vanderbilt University

Status and phase: Withdrawn; Phase 3

Conditions: Larynx Disease

Treatments: Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00567658

070730

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with vocal cord granulomas

Exclusion criteria

• Age < 18
• Pregnancy
• Use of proton pump inhibitor (PPI) within the last 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

A 1

Placebo Comparator group

Description:

Arm I: placebo group receives BID placebo

Treatment:

Drug: Esomeprazole

A2

Experimental group

Description:

subjects receive active drug, esomeprazole 40 mg BID

Treatment:

Drug: Esomeprazole