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This study has been withdrawn prior to enrollment.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 (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00567658
First received: December 3, 2007
Last updated: September 4, 2013
Last verified: August 2013

December 3, 2007
September 4, 2013
February 2008
January 2010   (final data collection date for primary outcome measure)
• Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories—subjectively assessed at laryngoscopy (current practice) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00567658 on ClinicalTrials.gov Archive Site
Symptom improvement +/- resolution [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Acid Suppression With Esomeprazole on Vocal Cord Granulomas
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Larynx Disease
Drug: Esomeprazole
Esomeprazole or Nexium 40 mg BID is given for four months.
  • Placebo Comparator: A 1
    Arm I: placebo group receives BID placebo
    Intervention: Drug: Esomeprazole
  • Experimental: A2
    subjects receive active drug, esomeprazole 40 mg BID
    Intervention: Drug: Esomeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with vocal cord granulomas

Exclusion Criteria:

  • Age < 18
  • Pregnancy
  • Use of proton pump inhibitor (PPI) within the last 30 days
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00567658
070730
No
Michael Vaezi, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Michael F Vaezi, MD, PhD, MS epi Vanderbilt University
Vanderbilt University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP