CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
lansoprazoledrug
Likely dose
Lansoprazole 30 mg orally twice daily for 1 yearAI-extracted
Key inclusion· 4
  • Adults with nasal polyposis
  • Not currently taking a PPI
  • Able and willing to undergo a noninvasive 24 hour pH probe study
  • Willing to take a PPI
Key exclusion· 3
  • Pregnant patients
  • History of surgical treatment for reflux disease
  • History of allergic or adverse reaction to Prevacid (lansoprazole)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00215787
NCT00215787N/ACompleted

Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

Head and Neck Surgery Associates·interventional·Posted Sep 22, 2005·Updated Sep 22, 2010

In Brief

A clinical study evaluating lansoprazole for Nasal Polyps and Gastroesophageal Reflux. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%. The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.8 years ago

Interventions

lansoprazoledrug

Lansoprazole 30 mg BID for 1 year