CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Esomeprazole +1 moredrug
Likely dose
Esomeprazole 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00287339
NCT00287339Phase 4Completed

Chronic Cough and Reflux Disease: A Randomized, Double-Blinded, Placebo Controlled Trial of High Dose Proton Pump Inhibition

University of North Carolina, Chapel Hill·interventional·Posted Feb 6, 2006·Updated Jan 10, 2012

In Brief

A Phase 4 clinical trial evaluating Esomeprazole and Placebo for Cough and GERD. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this research study is to investigate different doses of proton pump inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by lowering the amount of acid in the stomach. The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium), and is already marketed for treating GERD. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation), belching and coughing. Even very small, unnoticeable amounts of rising stomach acid may cause patients to cough. Because there may be a link between chronic cough and GERD, study doctors are interested in learning if giving high-dose Nexium (40 milligrams, twice daily) will help in treating chronic cough.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCough, GERD
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2006
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.4 years ago

Interventions

Esomeprazoledrug

40mg capsule BID for 12 weeks

Placebodrug

placebo capsule BID for 12 weeks