NCT00628667

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2002

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

1.1 years

First QC Date

February 26, 2008

Last Update Submit

January 24, 2011

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
1
PlaceboDRUG
2

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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 1, 2002

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

January 25, 2011

Record last verified: 2011-01