Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462111
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2007-04-16
Brief Title:
Indomethacin and Mechanisms Underlying Risk of Falling
Sponsor:
Sint Maartenskliniek
Organization:
Sint Maartenskliniek
Study Overview
Official Title:
Effect of Indomethacin on Reaction Time Postural Balance and the Ability to Avoid Suddenly Appearing Obstacles During Gait in Healthy Middle-aged Individuals
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether indometacin has an effect on reaction time postural stability and the avoidance of obstacles
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 andor
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
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 andor
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None