Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

January 24, 2011 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Esomeprazole
40mg orally twice daily
Other Names:
  • Nexium
Placebo Comparator: 2
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Dialy diary cards, investigator assessments, laryngoscopy at week 16
Dialy diary cards, investigator assessments, laryngoscopy at week 16

Secondary Outcome Measures

Outcome 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.
Time Frame: Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16
Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16
Quality of life Questionnaire
Time Frame: Quality of life questionnaire completed at screening and week 16
Quality of life questionnaire completed at screening and week 16
To evaluate the safety and tolerability by collecting an ongoing record of adverse events.
Time Frame: Ongoing to week 16.
Ongoing to week 16.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-NEE-0002
  • D9611C00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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