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Prevacid vs Lifestyle Modifications for the Treatment of LPR

NCT00274339 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2007-06-25

No results posted yet for this study

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.

Conditions

  • Laryngopharyngeal Reflux

Interventions

DRUG

Prevacid 30mg BID

BEHAVIORAL

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

Sponsors & Collaborators

  • TAP Pharmaceutical Products Inc.

    collaborator INDUSTRY

  • Hodge, Kenneth M., M.D.

    lead INDIV

Principal Investigators

  • Kenneth M Hodge, MD · Commonwealth Ear, Nose & Throat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00274339 on ClinicalTrials.gov