Back to resultsA Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Primary Purpose
Ischemia
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Moxaverine
physiological saline
Sponsored by
About this trial
This is an interventional treatment trial for Ischemia
Eligibility 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.
Sites / Locations
- Department of Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Retinal and Choroidal Blood flow
Secondary Outcome Measures
Full Information
NCT ID
NCT00569621
First Posted
December 5, 2007
Last Updated
December 5, 2007
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00569621
Brief Title
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Official Title
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Moxaverine
Intervention Description
intravenous administration
Intervention Type
Drug
Intervention Name(s)
physiological saline
Intervention Description
intravenous administration
Primary Outcome Measure Information:
Title
Retinal and Choroidal Blood flow
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wolzt, Prof
Organizational Affiliation
Department of Clinical Pharmacology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow
We'll reach out to this number within 24 hrs