Osteoarthritis PainPhase 1NCT01030640
Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
A Phase 1 study testing tanezumab in people with Osteoarthritis Pain and Chronic Low Back Pain, run by Pfizer at 2 sites in United States.
Trial summary
Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis Pain, Chronic Low Back Pain, Pain Due to Interstitial Cystitis
- What is being tested?
- tanezumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Sep 2010
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects only
- Female subjects can not be pregnant or be nursing.
- Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
- Can not have any problematic skin condition.
- Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy Volunteers
Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.
- Being tested
- placebo, tanezumab
- Keywords
- intraepidermal nerve fiber density, IENF, tanezumab, subcutaneous, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
single dose of the drug formulation
tanezumabBiological
single dose of the active drug tanezumab at a dose level of 20 mg
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | formulation without active drug Receives: Other: placebo |
| tanezumab | Active comparator | Not described Receives: Biological: tanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
Measured: 16 weeks
To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.
Measured: 16 weeks
To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
Measured: 16 weeks
Secondary outcomes (1)
To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis PainStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030640
- Sponsor's protocol ID
- A4091046
- Status last verified
- Apr 2011
- First submitted
- 9 Dec 2009
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01030640
- Acronym / sponsor ID
- A4091046
- Keywords
- intraepidermal nerve fiber density, IENF, tanezumab, subcutaneous, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Dec 2009 (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.
Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placeboformulation without active drug |
| tanezumab | Active comparator | Biological: tanezumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects only
- Female subjects can not be pregnant or be nursing.
- Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (3 listed)
- Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
- Can not have any problematic skin condition.
- Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week
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 |
|---|---|---|
| placebosingle dose of the drug formulation | Other | placebo |
| tanezumabsingle dose of the active drug tanezumab at a dose level of 20 mg | Biological | tanezumab |
Primary outcome
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
Time frame: 16 weeks
To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.
Time frame: 16 weeks
To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
Time frame: 16 weeks
1 secondary outcome
To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers
Time frame: 16 weeks
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 26 Apr 2011.
- 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.
Pfizer CT.gov Call Center study director
Pfizer
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 tanezumab in people with Osteoarthritis Pain and Chronic Low Back Pain, run by Pfizer 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 4 inclusion and 3 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 26 Apr 2011. 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?
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers. (time frame: 16 weeks). The study lists 3 primary outcomes in all. 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 26 Apr 2011.