NCT00369265

Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: American Institute for Voice and Ear Research · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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, improvement/resolution 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.

Conditions

• Laryngopharyngeal Reflux

Interventions

Type	Name	Description
DRUG	Lansoprazole	Lansoprazole 30mg twice daily
DIETARY_SUPPLEMENT	Sugar pill	placebo twice daily

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2006-08-29
• Last updated: 2012-08-24
• Results posted: 2012-08-17

Locations

3 sites across 1 country: United States