Prevacid vs Lifestyle Modifications for the Treatment of LPR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274339
Recruitment Status : Unknown
Verified June 2007 by Hodge, Kenneth M., M.D..
Recruitment status was:  Recruiting
First Posted : January 10, 2006
Last Update Posted : June 25, 2007
TAP Pharmaceutical Products Inc.
Information provided by:
Hodge, Kenneth M., M.D.

January 6, 2006
January 10, 2006
June 25, 2007
December 2005
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To compare the numbers of subjects with a Reflux Symptom Index score of less than 13 at visit 3 [ Time Frame: 6 months ]
To compare the numbers of subjects with a Reflux Symptom Index score of less than 13 in patients with LPR that take Prevacid 30mg BID and incorporate lifestyle modifications to patients that incorporate lifestyle modifications alone for 24 weeks.
Complete list of historical versions of study NCT00274339 on Archive Site
To evaluate the changes in Reflux Finding Score and Reflux Symptom Index from initial scores at screening to final assessment at visit 3. [ Time Frame: 6 months ]
To evaluate changes in the Reflux Finding Score and Reflux Symptom Index scores for all subjects from screening to week 24.
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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
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Laryngopharyngeal Reflux
  • Drug: Prevacid 30mg BID
  • Behavioral: Lifestyle changes of exercise and diet changes for weight loss and avoidance of reflux inducing foods.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
June 2008
Not Provided

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Hodge, Kenneth M., M.D.
TAP Pharmaceutical Products Inc.
Principal Investigator: Kenneth M Hodge, MD Commonwealth Ear, Nose & Throat
Hodge, Kenneth M., M.D.
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP