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

NCT02266537 | Completed Phase 1

• 1 other identifier: 527.70
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Sum of changes from baseline in the mean pupil diameters

  Baseline, 60 and 80 min after administration of phenylephrine (PE)

Secondary Outcomes (7)

• Change from baseline in mean diameter of both pupils

  Baseline, 60 and 80 min after administration of phenylephrine (PE)

• Change from baseline in mean diameter of both pupils

  one week after cessation of drug

• Concentration of the analyte in plasma

  Up to 29 days after first administration of α-antagonists

• Number of participants with clinically significant changes in vital signs

  Up to 8 days after last pupillometry

• Number of participants with abnormal changes in clinical laboratory parameters

  Up to 8 days after last pupillometry

Study Arms (4)

Tamsulosin

EXPERIMENTAL

Drug: Tamsulosin

Alfuzosin

EXPERIMENTAL

Drug: Alfuzosin

Doxazosin

EXPERIMENTAL

Drug: Doxazosin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tamsulosin DRUG

Also known as: Alna®

Tamsulosin

Alfuzosin DRUG

Also known as: Uroxatral® uno

Alfuzosin

Doxazosin DRUG

Also known as: Cardular PP Uro®

Doxazosin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Tamsulosin; AlnA protein, Acinetobacter radioresistens; alfuzosin; Doxazosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 17, 2014
• Study Start: November 1, 2005
• Primary Completion: February 1, 2006
• Last Updated: October 17, 2014

Record last verified: 2014-10