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Indometacin and Risk of Falling
This study is currently recruiting participants.
Verified by Sint Maartenskliniek, April 2007
First Received: April 16, 2007   Last Updated: July 27, 2007   History of Changes
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: 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

Resource links provided by NLM:


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

No publications provided

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

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

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
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010