Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas

Phase 3

Withdrawn

• Conditions: Larynx Disease
• Interventions: Drug: Esomeprazole

• Registration Number: NCT00567658
• Lead Sponsor: Vanderbilt University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-05
• Study Start: 2008-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with vocal cord granulomas

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A 1	Esomeprazole	Arm I: placebo group receives BID placebo
A2	Esomeprazole	subjects receive active drug, esomeprazole 40 mg BID

Primary Outcome Measures

Name	Time	Method
• Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories-subjectively assessed at laryngoscopy (current practice)	4 months

Secondary Outcome Measures

Name	Time	Method
Symptom improvement +/- resolution	4 months

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States