Status:
COMPLETED
A Study of Tanezumab in Adults With Chronic Low Back Pain
Lead Sponsor:
Pfizer
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 directe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
1359 Patients enrolled
Trial Details
Trial ID
NCT00876187
Start Date
June 15 2009
End Date
February 1 2011
Last Update
July 7 2021
Active Locations (135)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36201
2
Pinnacle Research Group LLC
Anniston, Alabama, United States, 36207
3
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
4
Simon Williamson Clinic, PC
Birmingham, Alabama, United States, 35211