Prevacid vs Lifestyle Modifications for the Treatment of LPR

NCT00274339 | Unknown

• 1 other identifier: LPR-04-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To compare the numbers of subjects with a Reflux Symptom Index score of less than 13 at visit 3

  6 months

Secondary Outcomes (1)

• 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

Interventions

Prevacid 30mg BID DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hodge, Kenneth M., M.D.: lead
• TAP Pharmaceutical Products Inc.: collaborator

Study Sites (1)

Commonwealth Ear, Nose & Throat

Louisville, Kentucky, 40207, United States

RECRUITING

Related Publications (9)

• Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.

  PMID: 12150380 BACKGROUND

• Belafsky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001 Aug;111(8):1313-7. doi: 10.1097/00005537-200108000-00001.

  PMID: 11568561 BACKGROUND

• 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.

  PMID: 12353425 BACKGROUND

• 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.

  PMID: 12353427 BACKGROUND

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

  PMID: 12353428 BACKGROUND

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

  PMID: 12353431 BACKGROUND

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

  PMID: 12353426 BACKGROUND

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

  PMID: 12353429 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Interventions

Lansoprazole; BID protein, human

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kenneth M Hodge, MD

  Commonwealth Ear, Nose & Throat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marti Gardner, MSN

CONTACT

502-893-0159; mgardner@commonwealthent.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 10, 2006
• Study Start: December 1, 2005
• Study Completion: June 1, 2008
• Last Updated: June 25, 2007

Record last verified: 2007-06

Locations

US (1)