Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00394056
Eligibility Criteria:
Inclusion criteria:
* Male or female subjects with a diagnosed tinnitus.
* Subject with THI severity grade of 3 or 4.
* Subjects willing to restrict alcohol intake.
* The subject must have given written consent.
* Women of childbearing potential who abstain from intercourse OR agree to birth control.
* Women of non-childbearing potential.
Exclusion criteria:
* Subject with THI severity grade = 5 or less than or equal to 2.
* Subject with pathologic level of anxiety or depression.
* Subject with no audiogram deficit and with normal hearing.
* Subjects that do not respond to the lidocaine infusion test or show a large variability in pre-infusion values.
* Subjects with any serious medical or surgical condition
* Subjects positive for drug use and/or a history of substance abuse or dependence.
* Subjects who have taken psychotropic drugs or antidepressants within specified time frames.
* Subjects who have recently used an investigational drug or recently participated in a trial.
* Subjects who have exhibited intolerance to NK1 antagonists or SSRIs.
* Women who have a positive pregnancy test.
* Female subjects who intend to get pregnant or male subjects who intend to father a child within the next 4 weeks following the last study drug administration in the study.
* Subjects, who have donated a unit of blood or more within the previous month or who intend to donate blood within one month of completing the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00394056
Study Brief:
Protocol Section:
NCT00394056