ClinicalTrials.gov
ClinicalTrials.gov Menu

Indomethacin and Mechanisms Underlying Risk of Falling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00462111
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : February 14, 2012
Sponsor:
Information provided by:
Sint Maartenskliniek

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Indometacin Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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.
Study Start Date : April 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Success rate on the obstacle avoidance task

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00462111     History of Changes
Other Study ID Numbers: SKM002
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

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