Prevacid vs Lifestyle Modifications for the Treatment of LPR

Not Applicable

• Conditions: Laryngopharyngeal Reflux

• Registration Number: NCT00274339
• Lead Sponsor: Hodge, Kenneth M., M.D.

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 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.

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. We will look at patients presenting with LPR symptoms in a community setting. All subjects will have an exam of their larynx via laryngoscopy at each of the 4 study visits (screening, week 6, week 12, and week 24). Based on exam findings, the physician will complete the Reflux Finding Score. The subjects will also complete the Reflux Symptom Index weekly to assess for changes in their symptoms. The statistical analysis of this study will include evaluating changes in the Reflux Finding Scores and Reflux Symptom Index scores over the 24 weeks of study participation.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-10
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-22
• Last Update Posted: 2007-06-25
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the numbers of subjects with a Reflux Symptom Index score of less than 13 at visit 3	6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the changes in Reflux Finding Score and Reflux Symptom Index from initial scores at screening to final assessment at visit 3.	6 months

Trial Locations

Locations (1)

Commonwealth Ear, Nose & Throat; 🇺🇸 Louisville, Kentucky, United States