Intraocular PressurePhase 1NCT01284309
A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
A Phase 1 study testing Mirabegron in people with Intraocular Pressure, run by Astellas Pharma Inc at 2 sites in United States.
Trial summary
The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Feb 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subject must be either post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month) or of childbearing potential with contraception. All women of childbearing potential will be required to use contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative urine pregnancy test
- Male subject with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period
- Subject may either be otherwise healthy or have symptoms of overactive bladder by self-report
Who cannot join
- History of glaucoma or ocular hypertension
- Abnormal visual field in either eye
- Ophthalmic condition that would interfere with reliable Goldmann tonometry (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca)
- History of major ocular infection, inflammation, or herpes simplex keratitis; evidence of current clinically significant blepharitis or conjunctivitis
- Any history of ocular surgery including refractive surgery such as laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) in any eye
- Ocular trauma within the past six months
Show all 17Show fewer
- Severe myopia
- Diabetes, Type I or Type 2, with or without medical management
- Cardiovascular disease requiring pharmacotherapy
- History of any type of dysrhythmia
- Systemic hypertension requiring pharmacotherapy
- Past diagnosis of any connective tissue or autoimmune disease including rheumatoid arthritis and spondyloarthropathies
- History of psychiatric illness requiring hospitalization
- Recent history (within past 24 months) of alcohol or other substance abuse (with the exception of nicotine)
- Used tobacco-containing products or nicotine-containing products within past 3 months
- Has been part of any clinical study past within 30 days or currently taking part in a clinical study other than the present study, or has participated in any previous study with mirabegron at any time
- Ocular medication of any kind within past 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion
Lincoln, Nebraska, 68502
Celerion
Tempe, Arizona, 85283
About this study
Official title: A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.
- Conditions
- Intraocular Pressure
- Being tested
- Mirabegron, Placebo
- Keywords
- Intraocular Pressure (IOP), YM178
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called YM178
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron | Experimental | Not described Receives: Drug: Mirabegron |
| 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.
Change from baseline to Day 56 in subject-average intraocular pressure (IOP)
Day 56 data will include subjects who discontinue early due to elevated IOP
Measured: Baseline and Day 56
Secondary outcomes (5)
Change from baseline to Day 10 in subject-average IOP
Measured: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10
Measured: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56
Measured: Baseline and Day 56
Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10
Measured: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56
Measured: Baseline and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284309
- Sponsor's protocol ID
- 178-CL-081
- Status last verified
- Mar 2011
- First submitted
- 25 Jan 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Novack GD, Lewis RA, Vogel R, Sheth N, Swearingen D, Rasmussen S, Hantsbarger G, Martin NE. Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers. J Ocul Pharmacol Ther. 2013 Sep;29(7):674-80. doi: 10.1089/jop.2012.0254. Epub 2013 Apr 15.
PubMed 23586728
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
- ClinicalTrials.gov ID
- NCT01284309
- Acronym / sponsor ID
- 178-CL-081
- Conditions
- Intraocular Pressure
- Keywords
- Intraocular Pressure (IOP), YM178
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Jan 2011 (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 purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabegron | Experimental | Drug: Mirabegron |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subject must be either post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month) or of childbearing potential with contraception. All women of childbearing potential will be required to use contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative urine pregnancy test
- Male subject with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period
- Subject may either be otherwise healthy or have symptoms of overactive bladder by self-report
Key exclusion criteria (17 listed)
- History of glaucoma or ocular hypertension
- Abnormal visual field in either eye
- Ophthalmic condition that would interfere with reliable Goldmann tonometry (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca)
- History of major ocular infection, inflammation, or herpes simplex keratitis; evidence of current clinically significant blepharitis or conjunctivitis
- Any history of ocular surgery including refractive surgery such as laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) in any eye
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 |
|---|---|---|
| MirabegronAlso: YM178oral | Drug | Mirabegron |
| Placebooral | Drug | Placebo |
Primary outcome
Change from baseline to Day 56 in subject-average intraocular pressure (IOP)
Time frame: Baseline and Day 56
Day 56 data will include subjects who discontinue early due to elevated IOP
5 secondary outcomes
Change from baseline to Day 10 in subject-average IOP
Time frame: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10
Time frame: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56
Time frame: Baseline and Day 56
Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10
Time frame: Baseline and Day 10
Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56
Time frame: Baseline and Day 56
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 11 Dec 2013.
- Derived from this study: PubMed 23586728Novack GD, Lewis RA, Vogel R, Sheth N, Swearingen D, Rasmussen S, Hantsbarger G, Martin NE. Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers. J Ocul Pharmacol Ther. 2013 Sep;29(7):674-80. doi: 10.1089/jop.2012.0254. Epub 2013 Apr 15.
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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.
Medical Director study director
Astellas Pharma Global Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mirabegron in people with Intraocular Pressure, run by Astellas Pharma Inc at 2 sites in United States.
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 3 inclusion and 17 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline to Day 56 in subject-average intraocular pressure (IOP) (time frame: Baseline and Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284309, which also lists 1 linked publication.
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 11 Dec 2013.