Prevacid vs Lifestyle Modifications for the Treatment of LPR

Laryngopharyngeal Reflux Clinical Trial

Official title:

A Comparison of Prevacid 30mg BID Plus Lifestyle Modifications Versus Lifestyle Modifications Alone for the Treatment of Laryngopharyngeal Reflux (LPR) in Adults

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00274339
• Other study ID #: LPR-04-01
• Status: Unknown status
• Phase: N/A
• First received: January 6, 2006
• Last updated: June 22, 2007
• Start date: December 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2007
• Source: Hodge, Kenneth M., M.D.
• Contact: Marti Gardner, MSN
• Phone: 502-893-0159
• Email: mgardner[@]commonwealthent.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 135
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Laryngopharyngeal Reflux

Intervention

Drug:
• Prevacid 30mg BID

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

Locations

Country	Name	City	State
United States	Commonwealth Ear, Nose & Throat	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Hodge, Kenneth M., M.D.	TAP Pharmaceutical Products Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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

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

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. — View Citation

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

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

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

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

Vaezy, M & Postma, GN. Laryngopharyngeal Reflux from an ENT and GI Perspective Course. October 21, 2004. Louisville, KY.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the numbers of subjects with a Reflux Symptom Index score of less than 13 at visit 3		6 months
Secondary	To evaluate the changes in Reflux Finding Score and Reflux Symptom Index from initial scores at screening to final assessment at visit 3.		6 months