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

This study has been completed.

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00569621

Purpose

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.

Condition	Intervention	Phase
Ischemia	Drug: Moxaverine Drug: physiological saline	Phase II

Drug Information available for: Sodium chloride Eupaverin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

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

Enrollment:	16
Study Start Date:	March 2007
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: Moxaverine intravenous administration
2: Placebo Comparator	Drug: physiological saline intravenous administration

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569621

Locations

Austria
Department of Clinical Pharmacology
Vienna, Austria, A-1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Michael Wolzt, Prof

Department of Clinical Pharmacology

More Information

Responsible Party:	Ursapharm Arzneimittel GmbH & Co. KG ( Dorothea Gross )
Study ID Numbers:	MOXOPH1
Study First Received:	December 5, 2007
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00569621
Health Authority:	Austria: Agency for Health and Food Safety

Study placed in the following topic categories:

Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009