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CompletedNCT00628667Updated Jan 25, 2011

Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

A Phase 4 interventional study of Esomeprazole and Placebo in Chronic Posterior Laryngitis (CPL), sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-25.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Posterior Laryngitis (CPL)

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Keywords

  • Chronic Posterior Laryngitis
  • CPL
  • Pharyngeal acid reflux
  • Esomeprazole
  • Nexium
03

In context

Laryngitis

14 studies on the registry are indexed under Laryngitis; 2 are open to participants now.

This study's planned enrollment of 120 is close to the median of 118 across 11 interventional studies indexed under Laryngitis.

Browse Laryngitis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    1

    Drug: Esomeprazole

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • 40mg orally twice daily

    Also known as: Nexium

  • DrugPlacebo
06

What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00628667
Lead sponsor
AstraZeneca
First posted
Mar 5, 2008
Start date
Feb 2002
Primary completion
Mar 2003
Completion
Mar 2003
Last update
Jan 25, 2011

Study contacts

Paula Fernstrom
study director · Nexium Global Product Director, AstraZeneca
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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