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Proton Pump Inhibitor
Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?
Nashville, TN
Phase 4
Waitlist Available
Led By Michael F Vaezi, MD,PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
The purpose of the study is to determine if tissue changes are predictor of clinical response to therapy. The hypothesis is that the patients who have laryngeal signs and symptoms related to acid reflux, will have ultrastructural changes on a laryngeal biopsy which are predictors of response to therapy.
See full description
Eligible Conditions
- Gastroesophageal Reflux Disease
- Laryngitis
- Acid Reflux
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with documented GERD or laryngopharyngeal refluxExperimental Treatment2 Interventions
Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lansoprazole
FDA approved
Esophageal and Laryngeal Biopsies
2007
Completed Phase 4
~40
Find a Location
Closest Location:Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410· Nashville, TN
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
918 Previous Clinical Trials
939,135 Total Patients Enrolled
Michael F Vaezi, MD,PhDPrincipal InvestigatorVanderbilt University
1 Previous Clinical Trials
10 Total Patients Enrolled