NCT00170001

Brief Summary

The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux (SER) will have complete resolution of those symptoms with adequate acid suppression when a PPI is administered for 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

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

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 15, 2011

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

September 12, 2005

Last Update Submit

December 13, 2011

Conditions

Gastroesophageal Reflux

Keywords

supraesophageal refluxlaryngopharyngeal symptomspharynxesophagus

Outcome Measures

Primary Outcomes (1)

  • To determine which symptom(s) are predictive of SER based on a complete response to PPI therapy

    1 month

Secondary Outcomes (4)

  • To determine which symptoms demonstrate partial response with PPI therapy

    1 month

  • To determine which features of a patient's history are predictive of a positive response to PPI therapy

    1 month

  • To determine which features of a patient's history are predictive of a lack of response to PPI therapy

    1 month

  • To develop a scoring system for the Supraesophageal Reflux Questionnaire (SRQ) that would predict a diagnosis of SER

    1 year

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR
Drug: Sugar Pill

Active Comparator

ACTIVE COMPARATOR
Drug: Nexium

Interventions

NexiumDRUG

40 mg bid dosing

Active Comparator
Sugar PillDRUG

40 mg BID

Sugar pill

Eligibility Criteria

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

You may qualify if:

  • Primary complaint includes one of the following symptoms: chronic cough (dry, hacking, or nocturnal), hoarseness, sore throat, globus sensation, or throat clearing. These symptoms will be identified by a yes response to SRQ (Appendix 7) items 2, 3, 4, 5, 6, and 8. Furthermore, symptom(s) must be chronic (present for at least 1 month), and recurrent (at least twice per week). These criteria correspond to SRQ columns on page 3-5. The first column asks: When in your life did you first notice this symptom? A response with either number 2, 3, 4, or 5 meets criteria for chronic. The second column asks: How frequently have you noticed the symptom? A response with either number 3, 4, or 5 meets criteria for recurrent.

You may not qualify if:

  • History of head and neck cancer/radiation/surgery (SRQ items 15, 16, 17)
  • History of esophagus/stomach surgery (SRQ item 22)
  • Peptic or duodenal ulcer disease; stomach or gastric ulcer disease; history of esophageal stricture, or Barrett's esophagus, or esophagitis, or tumor of the esophagus or stomach (SRQ item 23 and review of electronic surgical records of Mayo Clinic patients)
  • Presence of alarm symptoms (hemoptysis, unexplained loss of 10 or more pounds in the past 3 months), obtained from Appendix 5 for Community Subjects, medical record for clinic subjects. History of dysphagia, defined as a yes answer to SRQ item 7.
  • PPI use within 4 weeks, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
  • Use of warfarin or digoxin, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
  • Pregnancy at the time of enrollment, based on urine pregnancy test
  • Inability to understand or read English at a 6th grade level
  • Residence outside of the United States of America (USA)
  • Age younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

EsomeprazoleSugars

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yvonne Romero, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

December 15, 2011

Record last verified: 2011-12

Locations

US(1)