A Study of Tanezumab in Adults With Chronic Low Back Pain

Condition(s) targeted: Low Back Pain

Intervention: Tanezumab 20 mg IV (Biological); Placebo for naproxen (Drug); Tanezumab 10 mg IV (Biological); Placebo for naproxen (Drug); Tanezumab 5 mg IV (Biological); Placebo for naproxen (Drug); Placebo for tanezumab (Biological); Naproxen (Drug); Placebo for tanezumab (Biological); Placebo for naproxen (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from Baseline to Week 16 in the daily Low Back Pain Intensity (LBPI) as measured by an 11-point Numeric Rating Scale (NRS) for tanezumab vs placebo treatment

Secondary outcome:

Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) total score for tanezumab vs placebo

Change from Baseline to Week 16 in the Patient Global Assessment of Low Back Pain score for tanezumab vs placebo

Change from Baseline to Weeks 2, 4, 8, 12 and 16 (for tanezumab vs. naproxen only) in the LBPI NRS score.

Percent change from Baseline in the LBPI NRS score through Week 16.

Response as defined by a ≥30% and a ≥50% reduction from Baseline in the daily LBPI NRS score at Weeks 2, 4, 8, 12, and 16.

Time to a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score.

Total duration of response as defined by days with a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score.

Change from Baseline to Weeks 2, 4, 8, 12, and 16 in the Brief Pain Inventory short form (BPI sf) scores for Worst Pain and Average Pain.

Change from Baseline to Weeks 2, 4, 8, 12 and 16 (for tanezumab vs. naproxen) in RMDQ total score.

Change from Baseline to Weeks 2, 4, 8, 12, and 16 in the BPI sf score for the Pain Interference Index (composite function score), Pain Interference with General Activity, with Walking Ability, with Sleep, and with Normal Work.

Change from Baseline to Weeks 2, 4, 8, 12 and 16 (for tanezumab vs. naproxen) in PGA of Low Back Pain score.

Incidence of withdrawal due to lack of efficacy.

Chronic Low Back Pain Responder Index analysis [composite endpoint of Low Back Pain Intensity (NRS) score, PGA of Low Back Pain (disease activity), and RMDQ total score] at Weeks 2, 4, 8, 12, and 16

Incidence of patients, number of days, and amount of rescue medication use during Weeks 2, 4, 8, 12, and 16;

Safety measures: Adverse events; Safety laboratory testing (chemistry, hematology, urinalysis); Electrocardiogram (ECG); Neurological exam (Neuropathy Impairment Score [NIS]); Physical examinations; Vital signs.

Anti Drug Antibody (ADA) assessments at Baseline, and predose at Weeks 8, 16, and 24;

Measurement of plasma tanezumab concentrations (PK) at Baseline (predose and postdose), Week 4, predose and postdose at Week 8, and at Weeks 16 and 24;

Measurement of total and bound NGF at Baseline (predose and postdose), Week 4, predose and postdose at Week 8, and at Weeks 16 and 24.

Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) change from Baseline to Weeks 8 and 16 in the percent work time missed and other measures of productivity impairment due to CLBP.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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) such as NSAIDs, or mild opiates such as codeine, tramadol, or propoxyphene.

- 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 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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Hueytown, Alabama 35023, United States; Recruiting

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To obtain contact information for a study center near you, click here.

Starting date: June 2009
Ending date: June 2010
Last updated: September 16, 2009