NCT00462111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

April 16, 2007

Last Update Submit

February 13, 2012

Conditions

Healthy

Keywords

indometacinreaction timepostural balanceobstacle avoidanceaccidental falls

Outcome Measures

Primary Outcomes (1)

  • Success rate on the obstacle avoidance task

Secondary Outcomes (2)

  • Reaction time

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

Interventions

IndometacinDRUG

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Maartenskliniek

Nijmegen, 6522 JV, Netherlands

Location

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jacques van Limbeek, MD

    Sint Maartenskliniek

    PRINCIPAL INVESTIGATOR

  • Jaak Duysens, Prof

    St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 18, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

NL(1)