A Study of Tanezumab in Adults With Chronic Low Back Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID: NCT00876187
Run by: Pfizer
People needed: 1359
Starts: 2009-06-15
Expected to finish: 2011-02-01
Last updated by the study team: 2021-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Pinnacle Research Group LLC — Anniston, Alabama, United States
Pinnacle Research Group, LLC — Anniston, Alabama, United States
Simon Williamson Clinic, PC — Birmingham, Alabama, United States
Simon-Williamson Clinic, PC — Hueytown, Alabama, United States
Saadat Ansari, MD office — Huntsville, Alabama, United States
Horizon Research Group — Mobile, Alabama, United States
Radiant Research - Phoenix Southeast — Chandler, Arizona, United States
Pivotal Research Centers — Peoria, Arizona, United States
Arizona Research Center — Phoenix, Arizona, United States
Radiant Research, Inc.: Scottsdale, AZ — Scottsdale, Arizona, United States
Premiere Phamaceutical Research, LLC — Tempe, Arizona, United States
Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC — Tempe, Arizona, United States
Alta Clinical Research, LLC — Tucson, Arizona, United States
Little Rock Family Practice Clinic — Little Rock, Arkansas, United States
Providence Clinical Research — Burbank, California, United States
Valley Research — Fresno, California, United States
Collaborative Neuroscience Network, Inc — Garden Grove, California, United States
University of California San Diego — La Jolla, California, United States
Samaritan Center for Medical Research Medical Group — Los Gatos, California, United States
North County Clinical Research (NCCR) — Oceanside, California, United States
Advances in Medicine — Rancho Mirage, California, United States
Quality Control Research, Inc — Roseville, California, United States
Center for Clinical Trials of Sacramento, Inc. — Sacramento, California, United States
Wetlin Research Associates, Inc — San Diego, California, United States
Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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