A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 5, 2007

Last Updated Date

December 5, 2007

Start Date ^†

March 2007

Current Primary Outcome Measures ^†

Retinal and Choroidal Blood flow [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

Official Title ^†

A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

Brief Summary

It is known that several common eye diseases are associated with ocular perfusion abnormalities. Moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities because of its direct vasodilatory effects. The present study seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after intravenous administration.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment

Condition ^†

Ischemia

Intervention ^†

Drug: Moxaverine
Drug: physiological saline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

6 healthy volunteers of either sex
Age 18-35 yrs.
Body mass index between 15th and 85th percentile, nonsmokers

Exclusion Criteria:

Regular use of medication
Abuse of alcoholic beverages or drugs
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 3 dpt
Acute gastric bleeding, massive cerebral hemorrhage related to stroke
Women: pregnancy or lactation.

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Austria

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00569621

Responsible Party

Dorothea Gross, Ursapharm Arzneimittel GmbH & Co. KG

Secondary IDs ^††

Study Sponsor ^†

Medical University of Vienna

Collaborators ^††

Investigators ^†

Principal Investigator:

Michael Wolzt, Prof

Department of Clinical Pharmacology

Information Provided By

Medical University of Vienna

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.