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Indometacin and Risk of Falling

This study is currently recruiting participants.
Verified by Sint Maartenskliniek, April 2007

Sponsored by: 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

ChemIDplus related topics:   Indomethacin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Official Title:   Influence of Indometacin on Reaction Time, Postural Balance and the Avoidance of Obstacles in Healthy Subjects

Further study details as provided by Sint Maartenskliniek:

Primary Outcome Measures:
  • Success rate on the obstacle avoidance task

Secondary Outcome Measures:
  • Reaction time
  • Root mean square (RMS) of the velocity and amplitude of the centre of pressure (COP)

Estimated Enrollment:   20
Study Start Date:   April 2007

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.

  Eligibility
Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462111

Contacts
Contact: Judith Hegeman, MSc     +31 24 3659958     j.hegeman@maartenskliniek.nl    
Contact: Bart Nienhuis, Ir     +31 24 3659142     b.nienhuis@maartenskliniek.nl    

Locations
Netherlands
Sint Maartenskliniek     Recruiting
      Nijmegen, Netherlands, 6522 JV
      Contact: Judith Hegeman, MSc     +31 24 3659958     j.hegeman@maartenskliniek.nl    

Sponsors and Collaborators
Sint Maartenskliniek

Investigators
Principal Investigator:     Jacques van Limbeek, MD     Sint Maartenskliniek    
Study Chair:     Jaak Duysens, Prof     St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen    
  More Information


Study ID Numbers:   SKM002
First Received:   April 16, 2007
Last Updated:   July 27, 2007
ClinicalTrials.gov Identifier:   NCT00462111
Health Authority:   Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Sint Maartenskliniek:
indometacin  
reaction time  
postural balance  
obstacle avoidance  
accidental falls  

Study placed in the following topic categories:
Indomethacin
Healthy

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Reproductive Control Agents
Gout Suppressants
Pharmacologic Actions
Tocolytic Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 07, 2008




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