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OpenTrials
Completed

NCT Number: NCT00628667

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.

Completed

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Key information

Conditions

Chronic Posterior Laryngitis (CPL)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

40mg orally twice daily

Other names: Nexium

Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 5, 2008
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.