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.

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.

Condition or disease Intervention/treatment Phase
Laryngopharyngeal Reflux Drug: Prevacid 30mg BID Behavioral: Lifestyle changes of exercise and diet changes for weight loss and avoidance of reflux inducing foods. Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparison of Prevacid 30mg BID Plus Lifestyle Modifications Versus Lifestyle Modifications Alone for the Treatment of Laryngopharyngeal Reflux (LPR) in Adults
Study Start Date : December 2005
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00274339

Contact: Marti Gardner, MSN 502-893-0159 ext 1185

United States, Kentucky
Commonwealth Ear, Nose & Throat Recruiting
Louisville, Kentucky, United States, 40207
Contact: Marti Gardner, MSN    502-893-0159 ext 1185   
Principal Investigator: Kenneth M Hodge, MD         
Sub-Investigator: John R Morris, MD         
Sub-Investigator: Donald V Welsh, MD         
Sub-Investigator: Gorden T McMurry, MD         
Sub-Investigator: Andrew R Gould, MD         
Sub-Investigator: Keith D Forwith, PhD, MD         
Sub-Investigator: Steven D Shotts, MD         
Sub-Investigator: Tamalynn O'Daniel, MSN, ARNP         
Sub-Investigator: Jolene H Boswell, PA-C         
Sub-Investigator: Mary S McLaughlin, PA-C         
Sub-Investigator: Martha L Gardner, MSN, ARNP         
Sub-Investigator: Brian Walker, PA-C         
Sponsors and Collaborators
Hodge, Kenneth M., M.D.
TAP Pharmaceutical Products Inc.
Principal Investigator: Kenneth M Hodge, MD Commonwealth Ear, Nose & Throat

Publications: Identifier: NCT00274339     History of Changes
Other Study ID Numbers: LPR-04-01
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007

Keywords provided by Hodge, Kenneth M., M.D.:
Laryngopharyngeal Reflux
Lifestyle changes
Reflux Finding Score
Reflux Symptom Index

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action