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

NCT ID: NCT00569621

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Moxaverine

Intervention Type DRUG

intravenous administration

2

Group Type PLACEBO_COMPARATOR

physiological saline

Intervention Type DRUG

intravenous administration

Interventions

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Moxaverine

intravenous administration

Intervention Type DRUG

physiological saline

intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Ursapharm Arzneimittel GmbH & Co. KG

Principal Investigators

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Michael Wolzt, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology

Locations

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Department of Clinical Pharmacology

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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MOXOPH1

Identifier Type: -

Identifier Source: org_study_id