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Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis Pain, Chronic Low Back Pain, Pain Due to Interstitial Cystitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01030640
Pfizer
Completed
Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected

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Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Osteoarthritis Pain
  • Chronic Low Back Pain
  • Pain Due to Interstitial Cystitis
  • Other: placebo
    single dose of the drug formulation
  • Biological: tanezumab
    single dose of the active drug tanezumab at a dose level of 20 mg
  • Placebo Comparator: placebo
    formulation without active drug
    Intervention: Other: placebo
  • Active Comparator: tanezumab
    Intervention: Biological: tanezumab
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01030640
A4091046
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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