HealthyPhase 1NCT02266537
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
A Phase 1 study testing Tamsulosin, Alfuzosin and Doxazosin in people with Healthy, run by Boehringer Ingelheim.
Trial 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) Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tamsulosin, Alfuzosin and Doxazosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Feb 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
About this study
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
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
- Being tested
- Tamsulosin, Alfuzosin, Doxazosin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Alna®
AlfuzosinDrug
Also called Uroxatral® uno
DoxazosinDrug
Also called Cardular PP Uro®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | Not described Receives: Drug: Tamsulosin |
| Alfuzosin | Experimental | Not described Receives: Drug: Alfuzosin |
| Doxazosin | Experimental | Not described Receives: Drug: Doxazosin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of changes from baseline in the mean pupil diameters
Measured: Baseline, 60 and 80 min after administration of phenylephrine (PE)
Secondary outcomes (7)
Change from baseline in mean diameter of both pupils
Measured: Baseline, 60 and 80 min after administration of phenylephrine (PE)
Change from baseline in mean diameter of both pupils
Measured: one week after cessation of drug
Concentration of the analyte in plasma
Measured: Up to 29 days after first administration of α-antagonists
Number of participants with clinically significant changes in vital signs
Measured: Up to 8 days after last pupillometry
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to 8 days after last pupillometry
Number of participants with Adverse Events
Measured: Up to 8 days after last pupillometry
Assessement of global tolerability by investigator on a 4 point scale
Measured: 8 days after last pupillometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startNov 2005
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266537
- Sponsor's protocol ID
- 527.70
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 17 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02266537
- Acronym / sponsor ID
- 527.70
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2006 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: Tamsulosin |
| Alfuzosin | Experimental | Drug: Alfuzosin |
| Doxazosin | Experimental | Drug: Doxazosin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: Alna® | Drug | Tamsulosin |
| AlfuzosinAlso: Uroxatral® uno | Drug | Alfuzosin |
| DoxazosinAlso: Cardular PP Uro® | Drug | Doxazosin |
| Placebo | Drug | Placebo |
Primary outcome
Sum of changes from baseline in the mean pupil diameters
Time frame: Baseline, 60 and 80 min after administration of phenylephrine (PE)
7 secondary outcomes
Change from baseline in mean diameter of both pupils
Time frame: Baseline, 60 and 80 min after administration of phenylephrine (PE)
Change from baseline in mean diameter of both pupils
Time frame: one week after cessation of drug
Concentration of the analyte in plasma
Time frame: Up to 29 days after first administration of α-antagonists
Number of participants with clinically significant changes in vital signs
Time frame: Up to 8 days after last pupillometry
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 8 days after last pupillometry
Number of participants with Adverse Events
Time frame: Up to 8 days after last pupillometry
Assessement of global tolerability by investigator on a 4 point scale
Time frame: 8 days after last pupillometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tamsulosin, Alfuzosin and Doxazosin in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of changes from baseline in the mean pupil diameters (time frame: Baseline, 60 and 80 min after administration of phenylephrine (PE)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.