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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

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ClinicalTrials.gov Identifier: NCT00569621
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : December 7, 2007
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemia Drug: Moxaverine Drug: physiological saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Study Start Date : March 2007
Actual Study Completion Date : July 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Moxaverine
intravenous administration
Placebo Comparator: 2 Drug: physiological saline
intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Retinal and Choroidal Blood flow [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569621


Locations
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Austria
Department of Clinical Pharmacology
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Michael Wolzt, Prof Department of Clinical Pharmacology
More Information
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Responsible Party: Dorothea Gross, Ursapharm Arzneimittel GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00569621    
Other Study ID Numbers: MOXOPH1
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Moxaverine
Parasympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs