Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00628667

Purpose

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.

Condition	Intervention	Phase
Chronic Posterior Laryngitis (CPL)	Drug: Esomeprazole Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

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. [ 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. ]

Estimated Enrollment:	120
Study Start Date:	February 2002
Study Completion Date:	March 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Esomeprazole 40mg orally twice daily
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628667

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	SH-NEE-0002, D9611C00002
Study First Received:	February 26, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00628667 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Chronic Posterior Laryngitis
CPL
Pharyngeal acid reflux
Esomeprazole
Nexium

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Digestive System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Anti-Ulcer Agents
Laryngitis
Laryngeal Diseases
Esophageal Diseases

ClinicalTrials.gov processed this record on November 27, 2009