Indomethacin and Mechanisms Underlying Risk of Falling

This study has been completed.
Sponsor:
Information provided by:
Sint Maartenskliniek
ClinicalTrials.gov Identifier:
NCT00462111
First received: April 16, 2007
Last updated: February 13, 2012
Last verified: February 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

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
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Sint Maartenskliniek
Nijmegen, Netherlands, 6522 JV
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

ClinicalTrials.gov Identifier: NCT00462111     History of Changes
Other Study ID Numbers: SKM002
Study First Received: April 16, 2007
Last Updated: February 13, 2012
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:
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

ClinicalTrials.gov processed this record on July 20, 2014