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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00275730
Other study ID # 9-11-2004
Secondary ID
Status Completed
Phase N/A
First received January 11, 2006
Last updated February 9, 2007
Start date January 2006
Est. completion date August 2006

Study information

Verified date February 2007
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria:Bundesministerium für Gesundheit und Frauen
Study type Interventional

Clinical Trial Summary

Prostaglandins (PG) are known to alter regional ocular blood flow and exhibit vasoactive properties in isolated ocular blood vessels. A variety of animal experiments indicate that endogenous PGs play a role in the regulation of retinal (RBF) and choroidal (ChBF) blood flow. There is also evidence that the prostaglandin pathway is involved in the activation of NO production in humans, however, the mechanisms for interactions between PG and NO in ocular vasculature are still unclear.

Animal studies suggest that retinal and choroidal blood flow decrease after administration of indomethacin (a nonspecific cyclooxygenase inhibitor). More recently, it has been shown that indomethacin injected intravenously decreased optic nerve oxygen tension and reduced the CO2 reactivity. This is probably the result of decreased blood flow through vasoconstriction of vessels in the optic nerve. Systemic administration of indomethacin also diminishes cerebral, renal and mesenteric blood flow by an unknown mechanism. However, no clinical trials exist so far investigating the effects of indomethacin on ocular blood flow. Therefore, the aim of this study is to investigate the effect of indomethacin on ocular blood flow in healthy humans.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Men aged between 18 and 35 years, nonsmokers

- Body mass index between 15th and 85th percentile

- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant

- Normal ophthalmic findings, ametropy < 3 dpt.

Exclusion Criteria:

- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

- Treatment in the previous 3 weeks with any drug

- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs

- Blood donation during the previous 3 weeks

- Ametropy less than 3 dpt

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind


Related Conditions & MeSH terms


Intervention

Drug:
indometacine (drug) effect on ocular blood flow


Locations

Country Name City State
Austria Department of Clinical Pharmacology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal and choroidal blood flow
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