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Completed

NCT Number: NCT00462111

Indomethacin and Mechanisms Underlying Risk of Falling

The purpose of this study is to determine whether indometacin has an effect on reaction time, postural stability, and the avoidance of obstacles.

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Key information

Conditions

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sint Maartenskliniek

Nijmegen, 6522 JV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indometacin

Drug

Primary outcomes

  1. Success rate on the obstacle avoidance task

Secondary outcomes

  1. Reaction time

  2. Root mean square (RMS) of the velocity and amplitude of the centre of pressure (COP)

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Official study title

Effect of Indomethacin on Reaction Time, Postural Balance and the Ability to Avoid Suddenly Appearing Obstacles During Gait in Healthy Middle-aged Individuals.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 18, 2007
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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