NCT00628667CompletedPhase 4
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 Suspected Laryngopharyngeal Reflux
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 120
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness.
- •Patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria.
- •Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system.
Exclusion Criteria
- •A number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol.
- •If the patient is on certain medications this will also preclude them from taking part.
Arms & Interventions
1
Experimental
Intervention: Esomeprazole (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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.(Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16)
- Quality of life Questionnaire(Quality of life questionnaire completed at screening and week 16)
- To evaluate the safety and tolerability by collecting an ongoing record of adverse events.(Ongoing to week 16.)
Investigators
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