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

December 5, 2007
December 5, 2007
March 2007
Not Provided
Retinal and Choroidal Blood flow [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemia
  • Drug: Moxaverine
    intravenous administration
  • Drug: physiological saline
    intravenous administration
  • Experimental: 1
    Intervention: Drug: Moxaverine
  • Placebo Comparator: 2
    Intervention: Drug: physiological saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2007
Not Provided

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.
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00569621
MOXOPH1
Yes
Dorothea Gross, Ursapharm Arzneimittel GmbH & Co. KG
Medical University of Vienna
Not Provided
Principal Investigator: Michael Wolzt, Prof Department of Clinical Pharmacology
Medical University of Vienna
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP