Recruiting

Prevacid vs. Lifestyle Modifications

Sponsor:

Hodge, Kenneth M., M.D.

Code:

NCT00274339

Conditions

Laryngopharyngeal Reflux

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prevacid 30mg BID

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

Study Details

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.

Conditions

Laryngopharyngeal Reflux

Study ID

NCT00274339

Start date

Dec, 2005

Status verified date

Jun, 2007

Completion date

Jun, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Prevacid 30mg BID

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

Primary outcome measure

  • To compare the numbers of subjects with a Reflux Symptom Index score of less than 13 at visit 3 [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Marti Gardner, MSN

502-893-0159mgardner@commonwealthent.com

Locations

Commonwealth Ear, Nose & Throat

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Marti Gardner, MSN

502-893-0159mgardner@commonwealthent.com

Principal Investigator:

Kenneth M Hodge, MD

More Information

Sponsor

Hodge, Kenneth M., M.D.

Last update posted

Jun 25, 2007

Last verified

Jun, 2007

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hodge, Kenneth M., M.D. on 2007-06-25.