A Study of Tanezumab in Adults With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Tanezumab 20 mg IV; Placebo for naproxen; Tanezumab 10 mg IV; Placebo for naproxen; Tanezumab 5 mg IV; Placebo for naproxen; Placebo for tanezumab; Naproxen; Placebo for tanezumab; Placebo for naproxen
Intervention description: 2 IV administrations of tanezumab 20 mg at an 8 week interval; Oral placebo for naproxen twice a day for 16 weeks; 2 IV administrations of tanezumab 10 mg at an 8 week interval; Oral placebo for naproxen twice a day for 16 weeks; 2 IV administrations of tanezumab 5 mg at an 8 week interval; Oral placebo for naproxen twice a day for 16 weeks; 2 IV administrations of placebo for tanezumab at an 8 week interval; Oral naproxen 500 mg twice a day for 16 weeks; 2 IV administrations of placebo for tanezumab at an 8 week interval; Oral placebo for naproxen twice a day for 16 weeks
Intervention MeSH terms: Naproxen; Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1359.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: randomized controlled trial; monoclonal antibody; nerve growth factor; naproxen

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             study

          -  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:

          -  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
             months.

          -  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
             Baseline

          -  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
             NSAID.

          -  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
             biologics).

          -  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
             screening.

          -  History, diagnosis, or signs and symptoms of clinically significant neurological
             disease.

          -  History, diagnosis, signs or symptoms of any clinically significant psychiatric
             disorder.

          -  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.