NCT00567658

Brief Summary

The purpose of this research study is to measure the effects of the drug, esomeprazole 40 mg (Nexium) or placebo (inactive drug) on vocal cord granulomas.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 6, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

December 3, 2007

Last Update Submit

September 4, 2013

Conditions

Larynx Disease

Outcome Measures

Primary Outcomes (1)

  • • Primary outcome: Vocal cord granuloma improvement +/- resolution Outcome categories-subjectively assessed at laryngoscopy (current practice)

    4 months

Secondary Outcomes (1)

  • Symptom improvement +/- resolution

    4 months

Study Arms (2)

A 1

PLACEBO COMPARATOR

Arm I: placebo group receives BID placebo

Drug: Esomeprazole

A2

EXPERIMENTAL

subjects receive active drug, esomeprazole 40 mg BID

Drug: Esomeprazole

Interventions

EsomeprazoleDRUG

Esomeprazole or Nexium 40 mg BID is given for four months.

A 1A2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with vocal cord granulomas

You may not qualify if:

  • Age \< 18
  • Pregnancy
  • Use of proton pump inhibitor (PPI) within the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michael F Vaezi, MD, PhD, MS epi

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

February 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 6, 2013

Record last verified: 2013-08

Locations

US(1)