Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369265
Status:
TERMINATED
Last Update Posted:
2012-08-24
First Post:
2006-08-24
Brief Title:
Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
Sponsor:
American Institute for Voice and Ear Research
Organization:
American Institute for Voice and Ear Research
Study Overview
Official Title:
A Randomized Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pharmaceutical company purchased by another company and funding was terminated
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 study is to determine whether Lansoprazole 30mg taken twice daily is effective in the treatment of laryngitis due to gastroesophageal reflux
Detailed Description:
The investigators propose to study the effect of Lansoprazole 30 mg bid therapy vs placebo in patients who present with symptoms characteristic of reflux laryngitis The efficacy of Lansoprazole 30 mg bid in healing and improving reflux laryngitis will be determined For the purpose of this study healed reflux laryngitis will be defined as an improvement or resolution of arytenoid erythema and improvement in symptoms Improved reflux laryngitis will be defined as improvement in any two of the following areas arytenoid erythema voice quality as assessed by the patients or health care provider or improvementresolution of related symptoms throat clearing cough etc The impact of Lansoprazole 30 mg bid therapy on quality of life will be evaluated in a preliminary fashion
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