Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?

NCT00444145 | Completed Phase 4 Results

• 1 other identifier: 061244
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Larynx Disease; Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy

  Dilation of inter cellular spaces (the space within the cell) is reported to be an early morphological (structure and form) marker in gastro-oesophageal reflux. Using electron microscopy, the distance between epithelial cells is quantified.

  3 months

Study Arms (1)

Patients with documented GERD or laryngopharyngeal reflux

EXPERIMENTAL

Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.

Drug: Prevacid; Procedure: Esophageal and Laryngeal Biopsies

Interventions

Prevacid DRUG

30 mg bid for 3 months

Also known as: lansoprazole

Patients with documented GERD or laryngopharyngeal reflux

Esophageal and Laryngeal Biopsies PROCEDURE

repeat egd with biopsy after Prevacid 30 mg bid for 3 months

Also known as: esophagogastroduodenoscopy

Patients with documented GERD or laryngopharyngeal reflux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GERD
• Documented erosive esophagitis:
• Patients will be newly diagnosed with esophageal erosion at initial visit via EGD
• Patients with non-erosive esophagitis who have been responsive to PPI
• LPR
• Diagnosed via Head \& Neck Institute endoscopists:
• pts with chronic (\> 3-months) history of hoarseness, throat clearing, sore- or burning throat and globus
• Documentation of LPR using Larynx/Pharynx exam.
• This group is commonly evaluated at the Vanderbilt Voice Center.

You may not qualify if:

• Age \< 18yrs
• Pregnancy
• Patients with contra-indications for EGD
• Patients on corticosteroids
• Active smokers
• Patients with a history of regular (\> 2 /day) alcohol use.
• Use of antacid (PPI, H2RB) within last 30 days
• Use of any/all medications affecting gastrointestinal motility
• Known history of: Barrett's esophagus, Peptic stricture, Pyloric stenosis, Gastric resection
• Patients unable to give informed consent
• Patients unable to comply with follow-up
• Patients with known contraindication to lansoprazole.
• Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin, Plavix) or allergic to the local anesthetics.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410

Nashville, Tennessee, 37232-5280, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases; Gastroesophageal Reflux

Interventions

Lansoprazole; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Michael Vaezi
• Organization: Vanderbilt University

tina.higginbotham@vanderbilt.edu

615-322-3739

Study Officials

• Michael F Vaezi, MD,PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 7, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (1)