Prevacid vs Lifestyle Modifications for the Treatment of LPR
Status unconfirmed · Not applicable
Conditions studied: Laryngopharyngeal Reflux
In brief
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 Index and at least a 5 on the Reflux Finding Score. All subjects will receive education on lifestyle modifications with a nutritionist and exercise trainer. All subjects will be expected to comply with lifestyle modifications for the entire study period of 24 weeks. Half of all subjects will receive Prevacid 30mg BID and half will receive placebo BID for 24 weeks. Subjects will have 4 office visits over 24 weeks and weekly contacts with the study staff to assess Reflux Symptom Index and any health or medication changes.
Key facts
- Study ID
- NCT00274339
- Run by
- Hodge, Kenneth M., M.D.
- People needed
- 135
- Starts
- 2005-12-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2007-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Commonwealth Ear, Nose & Throat — Louisville, Kentucky, United States (enrolling)
Full record on ClinicalTrials.gov
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