A Study of Tanezumab in Adults With Chronic Low Back Pain
NCT00876187
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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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- Warwick, Rhode Island
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- Greer, South Carolina
- Rapid City, South Dakota
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- Carroltown, Texas
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Descriptive Information | ||||
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Brief Title ICMJE | A Study of Tanezumab in Adults With Chronic Low Back Pain | |||
Official Title ICMJE | A Randomized, Double-Blind, Multi-Dose, Active- and Placebo-Controlled, Multi-Center, Parallel Group Study of the Analgesic Effects of Tanezumab in Adult Patients With Chronic Low Back Pain | |||
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 directed against human nerve growth factor. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Low Back Pain | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1359 | |||
Original Estimated Enrollment ICMJE | 1000 | |||
Actual Study Completion Date ICMJE | February 2011 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00876187 | |||
Other Study ID Numbers ICMJE | A4091012 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | July 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |