A Randomized, Double-Masked, Placebo-Controlled Two Cross... | NCT00569621

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

NCT00569621

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Dec 7, 2007Estimated

Enrollment

16Actual

Phase

Phase 2

Conditions

Ischemia

Interventions

Moxaverine
physiological saline

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Dec 5, 2007

First Submission Date that Met QC Criteria

Dec 5, 2007

First Posted Date

Dec 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2007

Last Update Posted Date

Dec 7, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Moxaverine
2	Placebo Comparator		Drug: physiological saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moxaverine	Drug	intravenous administration	1
physiological saline

Measure	Description	Time Frame
Retinal and Choroidal Blood flow		2 hours

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Wolzt, Prof	Department of Clinical Pharmacology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Pharmacology		Vienna		A-1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D007511	Ischemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C004490	moxaverine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided