Back to resultsChronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
Primary Purpose
Chronic Posterior Laryngitis (CPL)
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Posterior Laryngitis (CPL) focused on measuring Chronic Posterior Laryngitis, CPL, Pharyngeal acid reflux, Esomeprazole, Nexium
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00628667
Brief Title
Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Posterior Laryngitis (CPL)
Keywords
Chronic Posterior Laryngitis, CPL, Pharyngeal acid reflux, Esomeprazole, Nexium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Quality of life Questionnaire
Time Frame
Quality of life questionnaire completed at screening and week 16
Title
To evaluate the safety and tolerability by collecting an ongoing record of adverse events.
Time Frame
Ongoing to week 16.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
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