A randomized, placebo-controlled study investigating the effects of moxaverine on ocular blood flow after oral administration in healthy subjects - MOXOPH3

• Conditions: healthy subjects; MedDRA version: 12.1Level: LLTClassification code 10038881Term: Retinal microcirculation disorder; MedDRA version: 12.1Level: HLTClassification code 10030067Term: Ocular vascular disorders NEC

• Registration Number: EUCTR2009-017789-22-AT
• Lead Sponsor: rsapharm Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Men and women aged between 18 and 35 years, nonsmokers
Body mass index between 16 and 30 kg/m²
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Normal ophthalmic findings, ametropia <6 dpt, anisometropia <2 dpt

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 the study drug
Blood donation during the previous 3 weeks
Presence of any ocular pathology that interferes with the aims of the present study
Hypersensitivity to moxaverine
Acute gastric bleeding, massive cerebral hemorrhage related to stroke
Women: pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of orally administrated moxaverine on ocular blood flow in young healthy subjects;Secondary Objective: none;Primary end point(s): Choroidal and optic nerve head blood flow (Laser Doppler Flowmetry)