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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Osteoarthritis Pain Chronic Low Back Pain Pain Due to Interstitial Cystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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placebo

formulation without active drug

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

single dose of the drug formulation

tanezumab

Group Type ACTIVE_COMPARATOR

tanezumab

Intervention Type BIOLOGICAL

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

Interventions

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placebo

single dose of the drug formulation

Intervention Type OTHER

tanezumab

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes