Prevacid vs Lifestyle Modifications for the Treatment of LPR

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2007 by Hodge, Kenneth M., M.D..
Recruitment status was Recruiting

Sponsor:

Collaborator:

TAP Pharmaceutical Products Inc.

Information provided by:

Hodge, Kenneth M., M.D.

ClinicalTrials.gov Identifier:

NCT00274339

First received: January 6, 2006

Last updated: June 22, 2007

Last verified: June 2007

History of Changes

Purpose

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	Intervention
Laryngopharyngeal Reflux	Drug: Prevacid 30mg BID Behavioral: Lifestyle changes of exercise and diet changes for weight loss and avoidance of reflux inducing foods.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness GERD

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Hodge, Kenneth M., M.D.:

Primary Outcome Measures:

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:

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 ]

Estimated Enrollment:	135
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274339

Contacts

Contact: Marti Gardner, MSN

502-893-0159 ext 1185

mgardner@commonwealthent.com

Locations

United States, Kentucky
Commonwealth Ear, Nose & Throat	Recruiting
Louisville, Kentucky, United States, 40207
Contact: Marti Gardner, MSN 502-893-0159 ext 1185 mgardner@commonwealthent.com
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.

Investigators

Principal Investigator:

Kenneth M Hodge, MD

Commonwealth Ear, Nose & Throat

More Information

Publications:

Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7.

Belafsky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001 Aug;111(8):1313-7.

Belafsky PC, Postma GN, Amin MR, Koufman JA. Symptoms and findings of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):10-3. Review.

Cohen JT, Bach KK, Postma GN, Koufman JA. Clinical manifestations of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):19-23. Review.

Koufman JA. Laryngopharyngeal reflux 2002: a new paradigm of airway disease. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):2-6. Review.

Koufman JA. Laryngopharyngeal reflux is different from classic gastroesophageal reflux disease. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):7-9. Review.

Postma GN, Belafsky PC, Aviv JE, Koufman JA. Laryngopharyngeal reflux testing. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):14-8. Review.

Postma GN, Johnson LF, Koufman JA. Treatment of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):24-6. Review.

ClinicalTrials.gov Identifier:	NCT00274339 History of Changes
Other Study ID Numbers:	LPR-04-01
Study First Received:	January 6, 2006
Last Updated:	June 22, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hodge, Kenneth M., M.D.:

Laryngopharyngeal Reflux
Prevacid
Lifestyle changes

Reflux Finding Score
Reflux Symptom Index
Laryngoscopy

Additional relevant MeSH terms:

Gastroesophageal Reflux
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013

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