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Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

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ClinicalTrials.gov Identifier: NCT00628667
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Chronic Posterior Laryngitis (CPL) Drug: Esomeprazole Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : February 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Esomeprazole
40mg orally twice daily
Other Name: Nexium
Placebo Comparator: 2 Drug: Placebo



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Quality of life Questionnaire [ Time Frame: Quality of life questionnaire completed at screening and week 16 ]
  3. To evaluate the safety and tolerability by collecting an ongoing record of adverse events. [ Time Frame: Ongoing to week 16. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628667


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00628667     History of Changes
Other Study ID Numbers: SH-NEE-0002
D9611C00002
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Chronic Posterior Laryngitis
CPL
Pharyngeal acid reflux
Esomeprazole
Nexium

Additional relevant MeSH terms:
Laryngopharyngeal Reflux
Laryngitis
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action