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| Sponsor: | Sint Maartenskliniek |
|---|---|
| Information provided by: | Sint Maartenskliniek |
| ClinicalTrials.gov Identifier: | NCT00462111 |
Purpose
The purpose of this study is to determine whether indometacin has an effect on reaction time, postural stability, and the avoidance of obstacles.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Indometacin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Influence of Indometacin on Reaction Time, Postural Balance and the Avoidance of Obstacles in Healthy Subjects |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2007 |
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:
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.
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judith Hegeman, MSc | +31 24 3659958 | j.hegeman@maartenskliniek.nl |
| Contact: Bart Nienhuis, Ir | +31 24 3659142 | b.nienhuis@maartenskliniek.nl |
| Netherlands | |
| Sint Maartenskliniek | Recruiting |
| Nijmegen, Netherlands, 6522 JV | |
| Contact: Judith Hegeman, MSc +31 24 3659958 j.hegeman@maartenskliniek.nl | |
| Principal Investigator: | Jacques van Limbeek, MD | Sint Maartenskliniek |
| Study Chair: | Jaak Duysens, Prof | St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen |
More Information
| ClinicalTrials.gov Identifier: | NCT00462111 History of Changes |
| Other Study ID Numbers: | SKM002 |
| Study First Received: | April 16, 2007 |
| Last Updated: | July 27, 2007 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
indometacin reaction time postural balance obstacle avoidance accidental falls |
|
Indomethacin Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |