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Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567658
Recruitment Status : Withdrawn (The decision of terminate the study was reached due to difficulties surrounding recruitment and enrollment of subjects since the inception of the study.)
First Posted : December 5, 2007
Last Update Posted : September 6, 2013
Information provided by (Responsible Party):
Michael Vaezi, 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.

Condition or disease Intervention/treatment Phase
Larynx Disease Drug: Esomeprazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Aggressive Acid Suppression With Esomeprazole on Vocal Cord Granulomas: Randomized Placebo-Controlled Trial
Study Start Date : February 2008
Actual Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. • Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories—subjectively assessed at laryngoscopy (current practice) [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Symptom improvement +/- resolution [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with vocal cord granulomas

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567658

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

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Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University Identifier: NCT00567658     History of Changes
Other Study ID Numbers: 070730
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Laryngeal Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action