Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628667

Enrollment

120

Registered

2008-03-05

Start date

2002-02-28

Completion date

2003-03-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Posterior Laryngitis (CPL)

Keywords

Chronic Posterior Laryngitis, CPL, Pharyngeal acid reflux, Esomeprazole, Nexium

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.

Interventions

DRUGEsomeprazole

40mg orally twice daily

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026