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Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas

This study has been withdrawn prior to enrollment.
(The decision of terminate the study was reached due to difficulties surrounding recruitment and enrollment of subjects since the inception of the study.)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00567658
First received: December 3, 2007
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Larynx Disease
 Drug: Esomeprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Aggressive Acid Suppression With Esomeprazole on Vocal Cord Granulomas: Randomized Placebo-Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • • Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories—subjectively assessed at laryngoscopy (current practice) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom improvement +/- resolution [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A 1
Arm I: placebo group receives BID placebo
 Drug: Esomeprazole
Esomeprazole or Nexium 40 mg BID is given for four months.
Experimental: A2
subjects receive active drug, esomeprazole 40 mg BID
 Drug: Esomeprazole
Esomeprazole or Nexium 40 mg BID is given for four months.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with vocal cord granulomas

Exclusion Criteria:

  • Age < 18
  • Pregnancy
  • Use of proton pump inhibitor (PPI) within the last 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567658

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Michael F Vaezi, MD, PhD, MS epi Vanderbilt University
  More Information

No publications provided

Responsible Party: Dr. Michael F. Vaezi, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00567658     History of Changes
Other Study ID Numbers: 070730
Study First Received: December 3, 2007
Last Updated: January 11, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Granuloma
Laryngeal Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013