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Ophthalmologic Examinations After Infusion of ZK200775

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00999284
First received: October 20, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) receptor and had earned attention a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within a stroke therapy related Phase I trial reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system will be analyzed in detail.

In a randomised, placebo-controlled, double-blind study eyes and vision will be examined before and after the intravenous administration of ZK 200775. The following methods will be applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and full-field electroretinogram (ERG).


Condition Intervention Phase
Visual Acuity
Drug: ZK200775
Drug: Sodium Chloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ophthalmologic Examinations After 4-hour Infusion of ZK200775 in Healthy Elder Male Volunteers

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Visual acuity

Secondary Outcome Measures:
  • Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram

Enrollment: 18
Study Start Date: December 1996
Study Completion Date: April 1998
Primary Completion Date: April 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Sham infusion of sodium chloride 0.9%
Drug: Sodium Chloride
Intravenous infusion of sodium chloride over a period of 4 hours.
Active Comparator: Low dose arm
Infusion of 0.3 mg/kg/h ZK200775 over 4 hours
Drug: ZK200775
Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
Active Comparator: High dose arm
Infusion of 0.75 mg/kg/h ZK200775 over 4 hours
Drug: ZK200775
Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.

  Eligibility

Ages Eligible for Study:   55 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The participant must be a voluntary proband
  • Age between 55 and 65 years
  • Body weight must not exceed the following value: Body height in cm minus 100 = body weight [kg] +/- 20%
  • Male sex
  • Written informed consent
  • Physical examination: Probands must show normal findings without clinical relevance, mental and physical health is required;

Exclusion Criteria:

  • Clinical history:

    • Substantial pre-existing medical condition
    • Known allergy to the employed effective components or galenic components
  • Medicaments and drugs

    • Intake of systemically or locally acting drugs which conflict with the aim of the trial or that can influence the results (antipsychotic drugs, antidepressants, barbiturates and benzodiazepines)
    • A clinical history that hints to substance or alcohol abuse
    • Nicotine abuse of more than 10 cigarettes a day
    • Consumption of alcoholic beverages on the day prior to the examinations
    • Extreme physical stress (sports or work) within 8 days prior to the examinations
    • Blood donation within 2 months prior to the examinations
    • Relevant vaccination or stay abroad
    • Special or onesided alimentation (strict vegetarianism, low-caloric diet)
    • Simultaneous participation in another clinical trial
  • Vital signs (after 3 minutes of rest)

    • Blood pressure with systolic values > 160 mmHg and / or diastolic values > 95 mmHg
    • Heart frequency: Values beyond 50-100 beats per minute
  • Electrocardiogram

    • abnormal 12-channel ECG
  • Laboratory findings

    • Hepatitis antigen (HBsAG), hepatitis C-antibodies or positive HIV-test
  • Clinical pharmacology

    • positive drug test
    • clinically relevant abnormalities of the examined parameters
  • Opinion of the investigator: when due to scientific or personal reasons or matters of compliance or safety a patient should not take part in the trial
  • Opacification of optic media, retinal disease, optic nerve disease, amblyopia or color vision defects
  • Status post intraocular surgery (exception: cataract surgery with implantation of a posterior chamber lens), laser coagulation
  • Myopia > -5 diopters, hyperopia > +5 diopters
  • Narrow angle glaucoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999284

Locations
Germany
Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Bayer
Investigators
Study Director: Thomas Staks, Dr. Bayer
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Thomas Staks, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00999284     History of Changes
Other Study ID Numbers: 96048
Study First Received: October 20, 2009
Last Updated: October 20, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
ZK200775 is tested for its effects on vision on healthy probands.

ClinicalTrials.gov processed this record on November 20, 2014