Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Posterior Laryngitis (CPL)

Keywords

Chronic Posterior LaryngitisCPLPharyngeal acid refluxEsomeprazoleNexium

Outcome Measures

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
Dialy diary cards, investigator assessments, laryngoscopy at week 16

Secondary Outcomes (3)

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.
Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16
Quality of life Questionnaire
Quality of life questionnaire completed at screening and week 16
To evaluate the safety and tolerability by collecting an ongoing record of adverse events.
Ongoing to week 16.

Study Arms (2)

1

EXPERIMENTAL

Drug: Esomeprazole

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EsomeprazoleDrug

40mg orally twice daily

Also known as: Nexium

PlaceboDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness.
Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system.

Sponsors & Collaborators

AstraZeneca
Industrylead

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Paula Fernstrom
Nexium Global Product Director, AstraZeneca
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 5, 2008

Study Start

February 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2003

Actual (reported)

Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record