A Study of Tanezumab in Adults With Chronic Low Back Pain | NCT00876187 | Trialant

A Study of Tanezumab in Adults With Chronic Low Back Pain | NCT00876187 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

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Anniston, Alabama 36201, United States

Pinnacle Research Group LLC

Anniston, Alabama 36207, United States

Pinnacle Research Group, LLC

Anniston, Alabama 36207, United States

Simon Williamson Clinic, PC

Birmingham, Alabama 35211, United States

Simon-Williamson Clinic, PC

Hueytown, Alabama 35023, United States

Saadat Ansari, MD office

Huntsville, Alabama 35801, United States

Horizon Research Group

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Peter A. Holt, MD

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The Center for Clinical Research

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Community Research

Cincinnati, Ohio 45227, United States

Sterling Research

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Rapid Medical Research, Inc.

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Christine Codding, MD

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Health Research of Oklahoma

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McBride Clinic

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Oklahoma City, Oklahoma 73112, United States

Sunstone Medical Research, LLC

Medford, Oregon 97504, United States

Summit Research Network (Oregon), Inc.

Portland, Oregon 97210, United States

Allegheny Pain Management

Altoona, Pennsylvania 16602, United States

East Penn Rheumatology Associates, PC

Bethlehem, Pennsylvania 18015, United States

Paramount Clinical Research

Bridgeville, Pennsylvania 15017, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania 16635, United States

CRI Worldwide LLC

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New England Center for Clinical Research

Cranston, Rhode Island 02920, United States

Omega Medical Research

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Columbia Arthritis Center, P.A.

Columbia, South Carolina 29204, United States

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Columbia, South Carolina 29204, United States

Radiant Research

Greer, South Carolina 29651, United States

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Johnson City, Tennessee 37601, United States

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Capitol Medical Clinic

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