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Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739635
First Posted: August 22, 2008
Last Update Posted: February 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
August 21, 2008
August 22, 2008
February 4, 2016
September 2008
February 2010   (Final data collection date for primary outcome measure)
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment [ Time Frame: Screening, Baseline, week 5, 13, 17 ]
Same as current
Complete list of historical versions of study NCT00739635 on ClinicalTrials.gov Archive Site
  • TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics [ Time Frame: 17 weeks ]
  • safety parameters [ Time Frame: 17 weeks ]
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, safety parameters, population pharmacokinetics, optional pharmacogenetics
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Subjective Tinnitus
  • Drug: Neramexane mesylate
    Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
  • Drug: Placebo
    Double-blind treatment period of 17 weeks placebo
  • Experimental: 1
    Intervention: Drug: Neramexane mesylate
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
411
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged 18 to 75 years with a clinical diagnosis of first onset,
  • Persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months

Exclusion Criteria:

  • Clinical diagnosis of intermittent or pulsatile tinnitus
  • Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Portugal,   Spain,   United Kingdom
 
 
NCT00739635
MRZ 92579/TI/3001
EudraCT Number 2007-007835-16
No
Not Provided
Not Provided
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Not Provided
Merz Pharmaceuticals GmbH
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP