Expired Study
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Nashville, Tennessee 37232


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.


Study summary:

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.


Criteria:

Inclusion Criteria: Patients with vocal cord granulomas Exclusion Criteria: - Age < 18 - Pregnancy - Use of proton pump inhibitor (PPI) within the last 30 days


Study is Available At:


Original ID:

070730


NCT ID:

NCT00567658


Secondary ID:


Study Acronym:


Brief Title:

Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

The decision of terminate the study was reac


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael F Vaezi, MD, PhD, MS epi
Principal Investigator
Vanderbilt University

Study Dates

Start Date:February 2008
Completion Date:January 2010
Completion Type:Anticipated
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:August 2013
Last Changed Date:September 4, 2013
First Received Date:December 3, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Symptom improvement +/- resolution
Time Frame:4 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:• Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories—subjectively assessed at laryngoscopy (current practice)
Time Frame:4 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Esomeprazole
Description:Esomeprazole or Nexium 40 mg BID is given for four months.
Arm Name:A 1

Study Arms

Study Arm Type:Experimental
Arm Name:A2
Description:subjects receive active drug, esomeprazole 40 mg BID
Study Arm Type:Placebo Comparator
Arm Name:A 1
Description:Arm I: placebo group receives BID placebo

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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