Prevacid vs Lifestyle Modifications for the Treatment of LPR

A Comparison of Prevacid 30mg BID Plus Lifestyle Modifications Versus Lifestyle Modifications Alone for the Treatment of Laryngopharyngeal Reflux (LPR) in Adults

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274339

Enrollment

135

Registered

2006-01-10

Start date

2005-12-31

Completion date

2008-06-30

Last updated

2007-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngopharyngeal Reflux

Keywords

Laryngopharyngeal Reflux, Prevacid, Lifestyle changes, Reflux Finding Score, Reflux Symptom Index, Laryngoscopy

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.

Interventions

DRUGPrevacid 30mg BID

BEHAVIORALLifestyle changes of exercise and diet changes for weight loss and avoidance of reflux inducing foods.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Contacts

Primary ContactMarti Gardner, MSN

mgardner@commonwealthent.com502-893-0159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026