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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030640
• Other study ID #: A4091046
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2009
• Last updated: April 22, 2011
• Start date: December 2009
• Est. completion date: September 2010

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Cystitis, Interstitial
• Low Back Pain
• Osteoarthritis Pain
• Pain Due to Interstitial Cystitis

Intervention

Other:
• placebo
single dose of the drug formulation

Biological:
• tanezumab
single dose of the active drug tanezumab at a dose level of 20 mg

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		16 weeks	Yes
Primary	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.		16 weeks	Yes
Primary	To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.		16 weeks	Yes
Secondary	To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers		16 weeks	No

External Links

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