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Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas

NCT ID: NCT00567658

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Larynx Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A 1

Arm I: placebo group receives BID placebo

Group Type PLACEBO_COMPARATOR

Esomeprazole

Intervention Type DRUG

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

A2

subjects receive active drug, esomeprazole 40 mg BID

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

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

Interventions

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Esomeprazole

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with vocal cord granulomas

Exclusion Criteria

* Age \< 18
* Pregnancy
* Use of proton pump inhibitor (PPI) within the last 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Michael Vaezi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael F Vaezi, MD, PhD, MS epi

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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070730

Identifier Type: -

Identifier Source: org_study_id