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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
Information provided by:

Study Description
Brief Summary:
Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.

Condition or disease Intervention/treatment Phase
Osteoarthritis Pain Chronic Low Back Pain Pain Due to Interstitial Cystitis Other: placebo Biological: tanezumab Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Study Start Date : December 2009
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo
formulation without active drug
Other: placebo
single dose of the drug formulation
Active Comparator: tanezumab Biological: tanezumab
single dose of the active drug tanezumab at a dose level of 20 mg

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030640

United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01030640     History of Changes
Other Study ID Numbers: A4091046
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Keywords provided by Pfizer:
intraepidermal nerve fiber density
healthy volunteers

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Cystitis, Interstitial
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases