Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274339
Status:
UNKNOWN
Last Update Posted:
2007-06-25
First Post:
2006-01-06
Brief Title:
Prevacid vs Lifestyle Modifications for the Treatment of LPR
Sponsor:
Hodge Kenneth M MD
Organization:
Hodge Kenneth M MD
Study Overview
Official Title:
A Comparison of Prevacid 30mg BID Plus Lifestyle Modifications Versus Lifestyle Modifications Alone for the Treatment of Laryngopharyngeal Reflux LPR in Adults
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None