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NCT00955799 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
A Phase 3 study, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
NCT00955799: Completed Phase 3 study, sponsored by Merz Pharmaceuticals.
NCT00955799 is a Phase 3 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 455 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00955799, a Phase 3 study, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
Primary Outcome
The TBF-12 is an adapted German version of the original English THI (Tinnitus Handicap Inventory). It is a self-report questionnaire assessing 12 items from 2 dimensions: emotional-cognitive factors and functional-communicational factors. Each item is rated with 0-2 (2= "often"; 1= "sometimes"; 0= "never"). The maximum score is 24 indicating most severe tinnitus impairment. Hierarchical test procedure: Step 1: week 29 in subjects reporting acute hearing loss; step 2: week 17, ditto; step 3: wee
Interventions
- DRUG Placebo
- DRUG Neramexane mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
What the finished NCT00955799 record still lists
NCT00955799 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00955799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00955799 about?
NCT00955799 is a clinical study titled "Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus". The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.
What is the current status of trial NCT00955799?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2009-09. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00955799?
The interventions under investigation include: Placebo (DRUG), Neramexane mesylate (DRUG).
Who is sponsoring clinical trial NCT00955799?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00955799's enrollment target sits among peer trials
455 829th of 2000 higher than 1,170 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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