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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Chronic Low Back Pain; Osteoarthritis Pain; Pain Due to Interstitial Cystitis

Treatments: Other: placebo; Biological: tanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030640

A4091046

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

formulation without active drug

Treatment:

Other: placebo

tanezumab

Active Comparator group

Treatment:

Biological: tanezumab