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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: American Institute for Voice and Ear Research

Current Primary Outcome: Percentage of Participants With Improvement or Resolution of Arytenoid Erythema [ Time Frame: 6 weeks ]

Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks


Original Primary Outcome: Improvement or Resolution of Arytenoid Erythema; Score on an Arytenoid Erythema Grading Scale Assigned by Member of Research Staff and Independent Observers at 6 Weeks.

Current Secondary Outcome:

Original Secondary Outcome:

  • Voice Quality Assessed Subjectively and Objectively at 6 Weeks.
  • Reflux Symptoms Assessed by Patients' Completion of Reflux Symptom Index at 6 Weeks.
  • Quality of Life Assessed by Patient Questionnaire at 6 Weeks.
  • Standard Objective Voice Measures Performed by Member of Research Staff at 6 Weeks.
  • Safety and Efficacy of Lansoprazole on Non-acid Laryngopharyngeal Reflux Will be Studied in Open-labeled, Uncontrolled, Single Group, Sub-study of 30 Patients Using the Same Primary and Secondary Outcome Measures.


Information By: American Institute for Voice and Ear Research

Dates:
Date Received: August 24, 2006
Date Started: August 2006
Date Completion:
Last Updated: August 23, 2012
Last Verified: August 2012