Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

Chronic Posterior Laryngitis (CPL) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628667
• Other study ID #: SH-NEE-0002
• Secondary ID: D9611C00002
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2008
• Last updated: January 24, 2011
• Start date: February 2002
• Est. completion date: March 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Posterior Laryngitis (CPL)
• Laryngitis
• Laryngopharyngeal Reflux

Intervention

Drug:
• Esomeprazole
40mg orally twice daily
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Dialy diary cards, investigator assessments, laryngoscopy at week 16
Secondary	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
Secondary	Quality of life Questionnaire		Quality of life questionnaire completed at screening and week 16
Secondary	To evaluate the safety and tolerability by collecting an ongoing record of adverse events.		Ongoing to week 16.