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

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569621
• Other study ID #: MOXOPH1
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: December 5, 2007
• Start date: March 2007
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia

Intervention

Drug:
• Moxaverine
intravenous administration
• physiological saline
intravenous administration

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal and Choroidal Blood flow		2 hours	No