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Prevacid vs Lifestyle Modifications for the Treatment of LPR

NCT ID: NCT00274339

Last Updated: 2007-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laryngopharyngeal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Prevacid 30mg BID

Intervention Type DRUG

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TAP Pharmaceutical Products Inc.

INDUSTRY

Sponsor Role collaborator

Hodge, Kenneth M., M.D.

INDIV

Sponsor Role lead

Principal Investigators

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Kenneth M Hodge, MD

Role: PRINCIPAL_INVESTIGATOR

Commonwealth Ear, Nose & Throat

Locations

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Commonwealth Ear, Nose & Throat

Louisville, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marti Gardner, MSN

Role: CONTACT

[email protected]
502-893-0159 ext. 1185

Facility Contacts

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Marti Gardner, MSN

Role: primary

[email protected]
502-893-0159 ext. 1185

References

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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.

Reference Type BACKGROUND
PMID: 12150380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11568561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12353425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12353427 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12353428 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12353431 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12353426 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12353429 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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LPR-04-01

Identifier Type: -

Identifier Source: org_study_id