Official Title: “Effect of Aggressive Acid Suppression With Esomeprazole on Vocal Cord Granulomas: Randomized Placebo-Controlled Trial”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: January 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • Esomeprazole or Nexium 40 mg BID is given for four months.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A 1
  • Arm I: placebo group receives BID placebo
• Active Comparator: A2
  • subjects receive active drug, esomeprazole 40 mg BID

Primary Measures

• • Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories—subjectively assessed at laryngoscopy (current practice)
  • Time Frame: 4 months
    Safety Issue?: No

Secondary Measures

• Symptom improvement +/- resolution
  • Time Frame: 4 months
    Safety Issue?: No

Inclusion Criteria:

• Patients with vocal cord granulomas

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Michael F. Vaezi, MD,PhD,MS epi Principal Investigator Vanderbilt University  

Overall Contact: marion goutte, bs 615-322-4332 marion.goutte@vanderbilt.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567658

Study ID Number: 070730

ClinicalTrials.gov Identifier: NCT00567658

Health Authority: United States: Food and Drug Administration