Status:
UNKNOWN
Prevacid vs Lifestyle Modifications for the Treatment of LPR
Lead Sponsor:
Hodge, Kenneth M., M.D.
Collaborating Sponsors:
TAP Pharmaceutical Products Inc.
Conditions:
Laryngopharyngeal Reflux
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate changes in scores on the Reflux Finding Score and Reflux Symptom Index over a 24 week period. To enroll subjects must score at least a 13 on the Reflux Symptom...
Detailed Description
The results of studies evaluating PPI therapy versus lifestyle modifications for the treatment of LPR have not been conclusive. However, many of these studies were conducted at tertiary care centers. ...
Eligibility Criteria
Inclusion
- Symptoms of LPR for at least one month, Score of 5 or greater on Reflux Finding Score, Score of 13 or greater on Reflux Symptom Index, and Willing to follow lifestyle modifications.
Exclusion
- Currently taking PPI twice daily for the treatment of LPR, Women who are pregnant or lactating, History of duodenal or gastric ulcer in the past 5 years, erosive esophagitis, or esophageal obstruction, History of any hypersecretory condition, History of Barrett's esophagus, History of hematemesis in the past 6 months, Currently taking ketoconazole, digoxin, Iron, ampicillin, theophylline, warfarin, or sucralfate, or Suspected disease of the larynx not related to LPR.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00274339
Start Date
December 1 2005
End Date
June 1 2008
Last Update
June 25 2007
Active Locations (1)
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1
Commonwealth Ear, Nose & Throat
Louisville, Kentucky, United States, 40207