A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Status and phase
Completed
Phase 2
Conditions
Ischemia
Treatments
Drug: physiological saline
Drug: Moxaverine
Details and patient eligibility
About
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.
Enrollment
16 patients
Sex
All
Ages
18 to 35 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
16 participants in 2 patient groups, including a placebo group
1
Experimental group
Treatment:
Drug: Moxaverine
2
Placebo Comparator group
Treatment:
Drug: physiological saline
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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