- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00462111
Indomethacin and Mechanisms Underlying Risk of Falling
Effect of Indomethacin on Reaction Time, Postural Balance and the Ability to Avoid Suddenly Appearing Obstacles During Gait in Healthy Middle-aged Individuals.
Study Overview
Detailed Description
A lot of (epidemiologic) research is done on causes for falls and factors contributing to falling. Most of this research was conducted on the elderly, either community-dwelling or institutionalised. It became clear that the elderly have a greater risk at falling because of:
- physiological changes due to increasing age [Gerdhem et al., 2005]
- previous falls [Myers et al., 1991; Lipsitz et al., 1992]
- comorbidity (including RA) [Bergland et al., 2004; Gerdhem et al., 2005; Lawlor et al., 2003]
- polypharmacy [Lawlor et al., 2003; Walker et al., 2005; Ziere et al., 2005] and/or
- use of specific drugs like antidepressives, benzodiazepines, vasodilators, and NSAIDs [Cumming R, 1998; Herings RMC, 2001; Kallin K et al., 2004; Granek et al., 1987].
The relation between benzodiazepines and falling has been extensively investigated in and affirmed by several fields of research and is practically common sense. However, the (possible) relation between NSAIDs and falling is much less investigated, even though there are various articles in which a higher risk of falling when using NSAIDs is stated; sometimes the risk is even as high as with benzodiazepines [Cumming R, 1998; Granek et al., 1987; Walker et al., 2005].
Objective of the study:
NSAIDs are drugs that are often prescribed to patients with rheumatic or orthopedic diseases. They seem to be at a greater risk for falls than healthy persons because of their disease, age and medication use. Therefore it is very important to keep this risk as small as possible. In this study healthy adults are measured on reaction time, postural balance and obstacle avoidance with and without use of indometacin or placebo. This is done in order to gain more comprehension in the mechanism and actual risk for falls when using NSAIDs.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Nijmegen, Netherlands, 6522 JV
- Sint Maartenskliniek
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Success rate on the obstacle avoidance task
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Secondary Outcome Measures
Outcome Measure |
---|
Reaction time
|
Root mean square (RMS) of the velocity and amplitude of the centre of pressure (COP)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacques van Limbeek, MD, Sint Maartenskliniek
- Study Chair: Jaak Duysens, Prof, St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Reproductive Control Agents
- Gout Suppressants
- Tocolytic Agents
- Indomethacin
Other Study ID Numbers
- SKM002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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