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NCT00596531 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of Acamprosate for Tinnitus
A Phase 1 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
NCT00596531 is a Phase 1 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 154 participants.
The verdict
NCT00596531, a Phase 1 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
Study Summary
The objective of this project is to determine whether acamprosate is more effective at providing relief for tinnitus than a placebo. Acamprosate has been suggested to be effective in reducing tinnitus annoyance in a preliminary study. Study evidence indicates that tinnitus is related to increased excitatory spontaneous brain activities. Acamprosate may help restore the excitatory/inhibitory balance in the brain and thus reduce tinnitus. The current study includes three phases. The first phase is an open-label screening study used to identify tinnitus subjects responding to acamprosate. These responding subjects will enter the second phase, which is a double blind, placebo-controlled study aimed at confirming the subjects' responses to acamprosate. In the third phase, clinical parameters of both responders and non-responders will be compared using a multi-linear regression model to determine characteristics that define the sub-group of tinnitus patients that are likely to benefit from acamprosate treatment. Participation in the study requires that individuals come to Portland, Oregon at least 6 times over 16 months for evaluation and data collection.
Interventions
- DRUG Placebo
- DRUG Acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2008-01 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00596531
The ClinicalTrials.gov registry entry for NCT00596531 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00596531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00596531 about?
NCT00596531 is a clinical study titled "Clinical Trial of Acamprosate for Tinnitus". The objective of this project is to determine whether acamprosate is more effective at providing relief for tinnitus than a placebo. Acamprosate has been suggested to be effective in reducing tinnitus annoyance in a preliminary study. Study evidence indicates that tinnitus is related to increased e...
What is the current status of trial NCT00596531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2008-01. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00596531?
The interventions under investigation include: Placebo (DRUG), Acamprosate (DRUG).
Who is sponsoring clinical trial NCT00596531?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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