Back to resultsStudy to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tamsulosin
Alfuzosin
Doxazosin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Healthy male
- Age ≥ 21 and ≤ 55 years
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
- Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on in-house trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range
- Excessive physical activities within the last week before the trial or during the trial
The following exclusion criteria are of special interest for this study:
- Hypersensitivity to any alpha agonist, or to phenylephrine
- Supine blood pressure at screening of systolic < 110 mmHg and diastolic < 60 mmHg
Ophthalmological criteria:
- Corrected visual acuity < 0.5
- Refractive Error with a spherical equivalent > +6 or smaller - 6 D
- Elevated intraocular pressure (higher than 22 mmHg)
- Relevant anisocoria or pupil deformation
- History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery
- Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study-start
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Tamsulosin
Alfuzosin
Doxazosin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Sum of changes from baseline in the mean pupil diameters
Secondary Outcome Measures
Change from baseline in mean diameter of both pupils
Change from baseline in mean diameter of both pupils
Concentration of the analyte in plasma
Number of participants with clinically significant changes in vital signs
Number of participants with abnormal changes in clinical laboratory parameters
Number of participants with Adverse Events
Assessement of global tolerability by investigator on a 4 point scale
Full Information
NCT ID
NCT02266537
First Posted
October 16, 2014
Last Updated
October 16, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02266537
Brief Title
Study to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers
Official Title
A Parallel Group Study With Three Different α-antagonists and Placebo Once Daily Over Three Weeks to Assess Their Influence on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The study was aimed to evaluate the pharmacological effect of different α-antagonists on phenylephrine induced pupil size in healthy male volunteers as pharmacological basis for Intraoperative floppy iris syndrome (IFIS)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tamsulosin
Arm Type
Experimental
Arm Title
Alfuzosin
Arm Type
Experimental
Arm Title
Doxazosin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Alna®
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Other Intervention Name(s)
Uroxatral® uno
Intervention Type
Drug
Intervention Name(s)
Doxazosin
Other Intervention Name(s)
Cardular PP Uro®
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Sum of changes from baseline in the mean pupil diameters
Time Frame
Baseline, 60 and 80 min after administration of phenylephrine (PE)
Secondary Outcome Measure Information:
Title
Change from baseline in mean diameter of both pupils
Time Frame
Baseline, 60 and 80 min after administration of phenylephrine (PE)
Title
Change from baseline in mean diameter of both pupils
Time Frame
one week after cessation of drug
Title
Concentration of the analyte in plasma
Time Frame
Up to 29 days after first administration of α-antagonists
Title
Number of participants with clinically significant changes in vital signs
Time Frame
Up to 8 days after last pupillometry
Title
Number of participants with abnormal changes in clinical laboratory parameters
Time Frame
Up to 8 days after last pupillometry
Title
Number of participants with Adverse Events
Time Frame
Up to 8 days after last pupillometry
Title
Assessement of global tolerability by investigator on a 4 point scale
Time Frame
8 days after last pupillometry
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male
Age ≥ 21 and ≤ 55 years
Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study
Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
Inability to refrain from smoking on in-house trial days
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
Any laboratory value outside the clinically accepted reference range
Excessive physical activities within the last week before the trial or during the trial
The following exclusion criteria are of special interest for this study:
Hypersensitivity to any alpha agonist, or to phenylephrine
Supine blood pressure at screening of systolic < 110 mmHg and diastolic < 60 mmHg
Ophthalmological criteria:
Corrected visual acuity < 0.5
Refractive Error with a spherical equivalent > +6 or smaller - 6 D
Elevated intraocular pressure (higher than 22 mmHg)
Relevant anisocoria or pupil deformation
History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery
Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study-start
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
Learn more about this trial
Study to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers
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