Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287339
Status:
COMPLETED
Last Update Posted:
2012-01-10
First Post:
2006-02-03
Brief Title:
The Utility of Nexium in Chronic Cough and Reflux Disease
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Chronic Cough and Reflux Disease A Randomized Double-Blinded Placebo Controlled Trial of High Dose Proton Pump Inhibition
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This study will be a randomized double-blind placebo controlled comparative parallel-group trial of subjects with chronic cough of unknown origin presenting to the Otolaryngology Head and Neck Surgery Pulmonary Medicine and Gastroenterology outpatient clinics at the University of North Carolina Hospital system
Potential subjects with chronic cough of unknown origin will be identified through the above outpatient clinics Those who meet the inclusion and exclusion criteria will be asked to join the study testing the efficacy of twice daily esomeprazole 40 mg taken for 3 months in the setting of chronic cough Potential subjects will be consented for the study prior to leaving the enrolling clinic A total of 40 subjects will be recruited into our study
Potential subjects with chronic cough of unknown origin will be identified through the above outpatient clinics Those who meet the inclusion and exclusion criteria will be asked to join the study testing the efficacy of twice daily esomeprazole 40 mg taken for 3 months in the setting of chronic cough Potential subjects will be consented for the study prior to leaving the enrolling clinic A total of 40 subjects will be recruited into our study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None