Clinical Trial: Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Double -Blind, Placebo-controlled Study to Evaluate the Effects of Esomeprazole 40mg Bid on the Signs and Symptoms of Chronic Posterior Laryngitis With Susp
Brief Summary: This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid [ Time Frame: Dialy diary cards, investigator assessments, laryngoscopy at week 16 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Daily diary cards and investigator symptom assessment throughout to evaluate the efficacy of acid suppression therapy on resolution of signs of CPL at weeks 8 and 16 in patients without documented pharyngeal acid reflux. [ Time Frame: Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16 ]
- Quality of life Questionnaire [ Time Frame: Quality of life questionnaire completed at screening and week 16 ]
- To evaluate the safety and tolerability by collecting an ongoing record of adverse events. [ Time Frame: Ongoing to week 16. ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: February 26, 2008
Date Started: February 2002
Date Completion:
Last Updated: January 24, 2011
Last Verified: January 2011
