A Study of Tanezumab in Adults With Chronic Low Back Pain

Summary

The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.

Conditions

• Low Back Pain

Interventions

BIOLOGICAL

Tanezumab 20 mg IV

2 IV administrations of tanezumab 20 mg at an 8 week interval

DRUG

Placebo for naproxen

Oral placebo for naproxen twice a day for 16 weeks

BIOLOGICAL

Tanezumab 10 mg IV

2 IV administrations of tanezumab 10 mg at an 8 week interval

DRUG

Placebo for naproxen

Oral placebo for naproxen twice a day for 16 weeks

BIOLOGICAL

Tanezumab 5 mg IV

2 IV administrations of tanezumab 5 mg at an 8 week interval

DRUG

Placebo for naproxen

Oral placebo for naproxen twice a day for 16 weeks

BIOLOGICAL

Placebo for tanezumab

2 IV administrations of placebo for tanezumab at an 8 week interval

DRUG

Naproxen

Oral naproxen 500 mg twice a day for 16 weeks

BIOLOGICAL

Placebo for tanezumab

2 IV administrations of placebo for tanezumab at an 8 week interval

DRUG

Placebo for naproxen

Oral placebo for naproxen twice a day for 16 weeks

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-15

Primary Completion

2010-06-16

Completion

2011-02-01

Countries

• United States

Study Locations