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A Study of Tanezumab in Adults With Chronic Low Back Pain

Last updated on March 14, 2019

Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Present with duration of low back pain of ≥3 months requiring regular use of analgesic
medication (>4 days per week for the past month). Analgesic medication may consist of
NSAIDs, selective COX-2 inhibitors, immediate release opioids, or combinations, with
certain protocol-defined limitations.

- Primary location of low back pain must be between the 12th thoracic vertebra and the
lower gluteal folds, with or without radiation into the posterior thigh

- Must meet criteria for pain severity and global assessment of low back pain at
Screening and Baseline visits

- Female patients of child-bearing potential (and male patients with female partners who
are of child-bearing potential) must use 2 methods of contraception throughout the

- Patients must be willing to discontinue all pain medications for chronic low back pain
except rescue medication and not use prohibited pain medications throughout the
duration of the study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- History of lumbosacral radiculopathy within the past 2 years.

- Back pain due to visceral disorder (eg, endometriosis).

- Back pain due to major trauma or osteoporotic compression fracture in the past 6

- History of rheumatoid arthritis, seronegative spondyloarthropathy, Paget's disease of
spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord.

- Surgical intervention during the past 6 months for the treatment of low back pain or
plans for surgical intervention during the course of the study.

- Current or pending worker's compensation, litigation, disability, or any other
monetary settlement regarding his/her CLBP or any other pain condition, or any closed
claim within the past 5 years.

- Use of any analgesic or muscle relaxant within 48 hours prior to the five days before

- Patients receiving only acetaminophen, gabapentin or pregabalin to manage their
chronic low back pain.

- Patients taking >325 mg/day of aspirin.

- Use of any antidepressants with the exception of stable treatment with selective
serotonin reuptake inhibitors (SSRIs).

- Use of any sedatives/hypnotics, anxiolytics, tranquilizers, or benzodiazepines unless
daily dose has been stable and will remain unchanged throughout the study period.

- Systemic corticosteroid therapy within 30 days (inhaled and topical corticosteroids
are permitted).

- Local or epidural injection of corticosteroids, as well as injections of
corticosteroids in the back within 3 months.

- Botulinum toxin (Botox®) injection for chronic low back pain within 4 months.

- Requirement for new, concomitant physiotherapy including, but not limited to,
transdermal electroneural stimulation (TENS), massage or spinal manipulation for the
duration of the study period.

- Active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration
within 3 months, or any history of gastrointestinal bleeding.

- Current use of lithium or anticoagulant agents.

- Known hypersensitivity or intolerance to NSAIDs; history of asthma, urticaria, or
allergic type reactions after taking aspirin or NSAIDs.

- Inflammatory bowel disease, a chronic or acute renal or hepatic disorder, a
significant coagulation defect, or other condition that might preclude the use of an

- History of intolerance to acetaminophen or paracetamol or any of its excipients.

- History of known alcohol, analgesic or narcotic abuse within 2 years.

- Presence of drugs of abuse (including prescription medications without a valid
prescription), other illegal drugs or marijuana in the urine toxicology screen
obtained at Screening.

- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
antibody or IgG fusion protein.

- Use of biologics other than study medication, including any live vaccines, within 3
months, or use during the study (intranasal Flumist® vaccine is an exception).

- Signs and symptoms of clinically significant cardiac disease.

- Diagnosis of a transient ischemic attack within the 6 months, or residual deficits
from stroke that would preclude completion of required study activities.

- History of cancer within 5 years.

- Use of any investigational medication within 30 days (3 months for investigational

- Expected to undergo a therapeutic procedure or to use any analgesic other than those
specified in the protocol throughout the study period.

- Previous exposure to exogenous NGF or to an anti NGF antibody.

- Screening laboratory results and blood pressure within specified limits.

- Positive Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) tests at

- History, diagnosis, or signs and symptoms of clinically significant neurological

- History, diagnosis, signs or symptoms of any clinically significant psychiatric

- Hospital admission for depression or suicide attempt within 5 years or active, severe
major depression at Screening.

- Likelihood of being non compliant with study procedures.

A Study of Tanezumab in Adults With Chronic Low Back Pain


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