Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01030640 |
Date of registration:
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09/12/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
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Scientific title:
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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 |
Date of first enrolment:
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December 2009 |
Target sample size:
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28 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01030640 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Low Back Pain
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Pain Due to Interstitial Cystitis
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Osteoarthritis Pain
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Intervention(s)
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Other: placebo
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Biological: tanezumab
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Primary Outcome(s)
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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]
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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]
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To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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