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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00712283 |
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Date of registration:
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03/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
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Scientific title:
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A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Group Design Study to Investigate the Effect of 12,5 mg, 25 mg, 50 mg and 75 mg Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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64 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00712283 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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Phase:
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Phase 1
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- healthy volunteers, female and male
- age 21 - 50
- BMI 18 - 30 kg/m2
- experienced drivers with a valid driver's license and at least 3 years of driving
practice
Exclusion Criteria:
- any clinically relevant finding on physical examination affecting the study
objectives
- clinically relevant abnormalities in the ECG laboratory values
- history or present evidence of clinically relevant metabolic, renal, hepatic,
pulmonary or cardiovascular disease, CNS disorders, or disturbance of bleeding
diagnosis of malignancy
- females who are pregnant or breastfeeding
Age minimum:
21 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Neramexane mesylate
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Primary Outcome(s)
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Fitness to drive
[Time Frame: 15 days]
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Secondary Outcome(s)
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Psychometric test and motor control tests
[Time Frame: 15 days]
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Secondary ID(s)
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MRZ 92579-0628/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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