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.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00569621
First received: December 5, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

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
Experimental: 1 Drug: Moxaverine
intravenous administration
Placebo Comparator: 2 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
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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

No publications provided

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

Additional relevant MeSH terms:
Moxaverine
Autonomic Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014