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Trial record 1 of 1 for:    NCT01030640
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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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ClinicalTrials.gov Identifier: NCT01030640
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 9, 2009
First Posted Date  ICMJE December 11, 2009
Last Update Posted Date April 26, 2011
Study Start Date  ICMJE December 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
Official Title  ICMJE 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
Brief Summary Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis Pain
  • Chronic Low Back Pain
  • Pain Due to Interstitial Cystitis
Intervention  ICMJE
  • Other: placebo
    single dose of the drug formulation
  • Biological: tanezumab
    single dose of the active drug tanezumab at a dose level of 20 mg
Study Arms  ICMJE
  • Placebo Comparator: placebo
    formulation without active drug
    Intervention: Other: placebo
  • Active Comparator: tanezumab
    Intervention: Biological: tanezumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2009)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01030640
Other Study ID Numbers  ICMJE A4091046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP