Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux - Tabular View

Tracking Information

First Received Date ^ICMJE

February 26, 2008

Last Updated Date

March 12, 2009

Start Date ^ICMJE

February 2002

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00628667 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
Quality of life Questionnaire [ Time Frame: 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. ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Posterior Laryngitis (CPL)

Intervention ^ICMJE

Drug: Esomeprazole
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

March 2003

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00628667

Responsible Party

Tore Lind, MD - Nexium Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

SH-NEE-0002, D9611C00002

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP