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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01378351
Other study ID # 011-085
Secondary ID
Status Terminated
Phase N/A
First received June 21, 2011
Last updated August 22, 2013
Start date June 2011
Est. completion date August 2012

Study information

Verified date August 2013
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to characterize the accompanying symptoms, evaluation and management of patients with chronic vestibular dysfunction presenting with nausea and vomiting.


Description:

Based on prior study, a significant portion of patients referred for refractory gastroparesis in fact have signs suggestive of vestibular dysfunction as the cause of chronic nausea and vomiting. Our prior retrospective study identified a population of said subjects.

The aim of this study is to further characterize the concomitant symptoms, course of diagnosis, treatment and long-term follow up (up to 5 yrs) of this condition.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- Clinical symptoms of nausea and vomiting for at least 4 weeks

- Abnormal modified Fukuda stepping test on examination (>90 degree rotation from midline while marching in place for 60 seconds) or nystagmus or abnormal Rhomberg test

Exclusion Criteria:

- Pregnancy

- Unable to complete questionnaire survey

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
Questionnaire survey
Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.

Locations

Country Name City State
United States Baylor University Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of nausea and vomiting 1 to 2 months No
Secondary Associated symptoms 1 to 2 months No
Secondary Alternate diagnoses 1 to 2 months No
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