Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Posterior Laryngitis (CPL)
Intervention: Esomeprazole (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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.
Clinical Details
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 Suspected Laryngopharyngeal Reflux
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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
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.Quality of life Questionnaire To evaluate the safety and tolerability by collecting an ongoing record of adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: February 2002
Ending date: May 2003
Last updated: March 4, 2008
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