Hearing Loss, SensorineuralPhase 1NCT01518920
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
A Phase 1 study testing PF-04958242 in people with Hearing Loss, Sensorineural, run by Biogen at 11 sites in United States.
Trial summary
The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- PF-04958242
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2011to Feb 2013
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 dB, averaged over 2 and 4 kHz in at least one ear.
- Subjects must have symmetric hearing loss
- Subjects who can read, speak and comprehend English.
Who cannot join
- Subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss
- Subjects who have hearing disorders other than age related sensorineural hearing loss
- Subjects with moderate or greater tinnitus
- Pregnant females; breastfeeding females; females of childbearing potential
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Dallas, Texas, 75390-8575
Pfizer Investigational Site
Dallas, Texas, 75390-8868
Pfizer Investigational Site
Dallas, Texas, 75390-8891
Pfizer Investigational Site
Dallas, Texas, 75390-9035
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
New Haven, Connecticut, 06511
Pfizer Investigational Site
New Haven, Connecticut, 06519
Pfizer Investigational Site
New Haven, Connecticut, 06520-8071
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-04958242 In Subjects With Age-Related Sensorineural Hearing Loss
The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.
Read the detailed description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- PF-04958242, Placebo
- Keywords
- Age related sensorineural hearing loss, PF-04958242
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04958242Drug
PF-04958242 0.35 mg oral solution
PF-04958242Drug
PF-04958242 0.27 mg oral solution
PlaceboDrug
Placebo oral solution
| Study group | Role | What they receive |
|---|---|---|
| PF-04958242 | Experimental | Not described Receives: Drug: PF-04958242 |
| 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 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz
Measured: 1 hour
Secondary outcomes (5)
Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz
Measured: 5 hours
Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score
Measured: 1 hour, 5 hours
Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing
Measured: 1 hour, 5 hours
Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale
Measured: 1 hour, 5 hours
Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.
Measured: 45 min, 1 hour, 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
- Study completionFeb 2013
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 Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518920
- Sponsor's protocol ID
- B1701005
- Status last verified
- Nov 2019
- First submitted
- 23 Jan 2012
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bednar MM, DeMartinis N, Banerjee A, Bowditch S, Gaudreault F, Zumpano L, Lin FR. The Safety and Efficacy of PF-04958242 in Age-Related Sensorineural Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Jul;141(7):607-13. doi: 10.1001/jamaoto.2015.0791.
PubMed 25997115
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-04958242 In Subjects With Age-Related Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT01518920
- Acronym / sponsor ID
- B1701005
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Age related sensorineural hearing loss, PF-04958242
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Jan 2012 (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 objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.
Detailed description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04958242 | Experimental | Drug: PF-04958242 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 dB, averaged over 2 and 4 kHz in at least one ear.
- Subjects must have symmetric hearing loss
- Subjects who can read, speak and comprehend English.
Key exclusion criteria (4 listed)
- Subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss
- Subjects who have hearing disorders other than age related sensorineural hearing loss
- Subjects with moderate or greater tinnitus
- Pregnant females; breastfeeding females; females of childbearing potential
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 |
|---|---|---|
| PF-04958242PF-04958242 0.35 mg oral solution | Drug | PF-04958242 |
| PF-04958242PF-04958242 0.27 mg oral solution | Drug | PF-04958242 |
| PlaceboPlacebo oral solution | Drug | Placebo |
Primary outcome
Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz
Time frame: 1 hour
5 secondary outcomes
Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz
Time frame: 5 hours
Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score
Time frame: 1 hour, 5 hours
Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing
Time frame: 1 hour, 5 hours
Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale
Time frame: 1 hour, 5 hours
Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.
Time frame: 45 min, 1 hour, 5 hours
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 21 Nov 2019.
- Derived from this study: PubMed 25997115Bednar MM, DeMartinis N, Banerjee A, Bowditch S, Gaudreault F, Zumpano L, Lin FR. The Safety and Efficacy of PF-04958242 in Age-Related Sensorineural Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Jul;141(7):607-13. doi: 10.1001/jamaoto.2015.0791.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
Biogen
11 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 PF-04958242 in people with Hearing Loss, Sensorineural, run by Biogen at 11 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 4 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 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz (time frame: 1 hour). 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 NCT01518920, 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 21 Nov 2019.