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Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain

Last updated on April 18, 2019

Study Location
Meitoh Hospital
Nagoya, Aichi, 465-0025 Japan
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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- Duration of chronic low back pain for ≥3 months, and treatment with agents for low
back pain for ≥3 months.

- 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, classified as
Category 1 or 2 according to the classification of the Quebec Task Force in Spinal

- Subjects must be experiencing some benefits from their current stable dose regimen of
oral NSAID (celecoxib, loxoprofen or meloxicam) treatment as described in the
protocol, be tolerating their NSAID regimen, be taking this medication regularly
during the 30 day period prior to the Screening visit and must have had some
improvement in low back pain, but still require additional pain relief at Screening.

- Subjects must maintain a stabilized, protocol specified NSAID dose regimen for at
least the final 2 or 3 weeks of the Screening period.

- Low Back Pain Intensity (LBPI) score of ≥5 at Screening.

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

- Female subjects of childbearing potential and at risk for pregnancy must agree to
comply with protocol specified contraceptive requirements.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects exceeding protocol defined BMI limits.

- Diagnosis of osteoarthritis of the knee or hip as defined by the ACR combined clinical
and radiographic criteria.

- Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or
Grade > or =3 radiographic evidence of knee osteoarthritis will be excluded.

- Subjects who have Kellgren Lawrence Grade osteoarthritis but who do not meet ACR criteria and do not have pain associated
with their knee osteoarthritis will be allowed.

- Subjects with symptoms and radiologic findings consistent with osteoarthritis in the

- History of lumbosacral radiculopathy within the past 2 years, history of spinal
stenosis associated with neurological impairment, or history of neurogenic

- Back pain due to recent major trauma within 6 months prior to Screening.

- Surgical intervention during the past 6 months for the treatment of low back pain.

- Planned surgical procedure during the duration of the study.

- History or radiographic evidence of other diseases that could confound efficacy or
safety assessments (eg, rheumatoid arthritis).

- History or radiographic evidence of orthopedic conditions that may increase the risk
of, or confound assessment of joint safety conditions during the study.

- History of osteonecrosis or osteoporotic fracture.

- History of significant trauma or surgery to a knee, hip, or shoulder within the
previous year.

- Signs or symptoms of carpal tunnel syndrome in the one year prior to Screening.

- Considered unfit for surgery based upon American Society of Anesthesiologists physical
classification system for surgery grading, or subjects who would not be willing to
undergo joint replacement surgery if required.

- History of intolerance or hypersensitivity to celecoxib/acetaminophen or any of its
excipients or existence of a medical condition or use of concomitant medication for
which the use of celecoxib/acetaminophen is contraindicated.

- Use of prohibited medications or prohibited non-pharmacological treatments without the
appropriate washout period (if applicable) prior to Screening or IPAP.

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

- Presence of drugs of abuse or illegal drugs in the urine toxicology screen obtained at

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

- Signs and symptoms of clinically significant cardiac disease.

- Poorly controlled hypertension as defined in the protocol or taking an
antihypertensive that has not been stable for at least 1 month prior to Screening.

- Evidence of protocol defined orthostatic hypotension at Screening.

- Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening.

- Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis
of stroke with residual deficits that would preclude completion of required study

- History of cancer within 5 years prior to Screening, except for cutaneous basal cell
or squamous cell cancer resolved by excision.

- Expected to undergo a therapeutic procedure or to use any analgesic other than those
specified in the protocol throughout the pre-treatment and treatment periods that is
likely to confound assessment of analgesic efficacy or safety.

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

- Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined

- Positive Hepatitis B, Hepatitis C, or HIV tests at screening indicative of current

- History, diagnosis, or signs and symptoms of clinically significant neurological
disease or clinically significant psychiatric disorder.

- Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling
or unable to follow protocol required contraceptive requirements.

- Participation in other investigational drug studies within protocol defined time

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that in the judgment of the investigator, would make the subject
inappropriate for entry into this study.

Active, not recruiting
Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain


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