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

NCT00569621 | Completed Phase 2 DMC

• 1 other identifier: MOXOPH1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

• Retinal and Choroidal Blood flow

  2 hours

Study Arms (2)

1

EXPERIMENTAL

Drug: Moxaverine

2

PLACEBO COMPARATOR

Drug: physiological saline

Interventions

Moxaverine DRUG

intravenous administration

1

physiological saline DRUG

intravenous administration

2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers of either sex
• Age 18-35 yrs.
• Body mass index between 15th and 85th percentile, nonsmokers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Ischemia

Interventions

moxaverine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Wolzt, Prof

  Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: March 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 7, 2007

Record last verified: 2007-12

Locations

AU (1)