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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00462111 |
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Date of registration:
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16/04/2007 |
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Primary sponsor: |
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Public title:
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Indomethacin and Mechanisms Underlying Risk of Falling
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Scientific title:
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Effect of Indomethacin on Reaction Time, Postural Balance and the Ability to Avoid Suddenly Appearing Obstacles During Gait in Healthy Middle-aged Individuals. |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00462111 |
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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: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Jacques van Limbeek, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sint Maartenskliniek |
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Name:
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Jaak Duysens, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between 50-70 years old
- Not using any non-steroidal anti-inflammatory drugs (NSAIDs) for at least 3 days
prior to the test session
Exclusion Criteria:
- Neurological or orthopedic disorders
- Poor comprehension of Dutch language
- Hearing problems
- Severe problems with heart and/or blood vessels
- Acutely existing ulcus ventriculi and/or duodeni, or history of ulcus
- Allergy against indomethacin, aspirin, or other NSAIDs
- Patients with nasal polyps reacting with an angioedema to other NSAIDs
- Severe preexisting renal and liver damage
- Co-medication
- Over 100 kg of weight
Age minimum:
50 Years
Age maximum:
70 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: Indometacin
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Primary Outcome(s)
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Success rate on the obstacle avoidance task
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Secondary Outcome(s)
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Reaction time
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Root mean square (RMS) of the velocity and amplitude of the centre of pressure (COP)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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