A Study of Tanezumab in Adults With Chronic Low Back Pain - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00876187

Purpose

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.

Condition	Intervention	Phase
Low Back Pain	Biological: Tanezumab 20 mg IV Drug: Placebo for naproxen Biological: Tanezumab 10 mg IV Biological: Tanezumab 5 mg IV Biological: Placebo for tanezumab Drug: Naproxen	Phase II

MedlinePlus related topics: Back Pain

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) total score for tanezumab vs placebo [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Change from Baseline to Week 16 in the Patient Global Assessment of Low Back Pain score for tanezumab vs placebo [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Change from Baseline to Weeks 2, 4, 8, 12 and 16 (for tanezumab vs. naproxen only) in the LBPI NRS score. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Percent change from Baseline in the LBPI NRS score through Week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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 Frame: Week 16 ] [ Designated as safety issue: No ]
Time to a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Total duration of response as defined by days with a ≥30% and a ≥50% reduction from Baseline in the daily average LBPI NRS score. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Change from Baseline to Weeks 2, 4, 8, 12 and 16 (for tanezumab vs. naproxen) in RMDQ total score. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Change from Baseline to Weeks 2, 4, 8, 12 and 16 (for tanezumab vs. naproxen) in PGA of Low Back Pain score. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Incidence of withdrawal due to lack of efficacy. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Incidence of patients, number of days, and amount of rescue medication use during Weeks 2, 4, 8, 12, and 16; [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Safety measures: Adverse events; Safety laboratory testing (chemistry, hematology, urinalysis); Electrocardiogram (ECG); Neurological exam (Neuropathy Impairment Score [NIS]); Physical examinations; Vital signs. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Anti Drug Antibody (ADA) assessments at Baseline, and predose at Weeks 8, 16, and 24; [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
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; [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tanezumab 20 mg IV: Experimental	Biological: Tanezumab 20 mg IV 2 IV administrations of tanezumab 20 mg at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks
Tanezumab 10 mg IV: Experimental	Biological: Tanezumab 10 mg IV 2 IV administrations of tanezumab 10 mg at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks
Tanezumab 5 mg IV: Experimental	Biological: Tanezumab 5 mg IV 2 IV administrations of tanezumab 5 mg at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks
Naproxen: Active Comparator	Biological: Placebo for tanezumab 2 IV administrations of placebo for tanezumab at an 8 week interval Drug: Naproxen Oral naproxen 500 mg twice a day for 16 weeks
Placebo: Placebo Comparator	Biological: Placebo for tanezumab 2 IV administrations of placebo for tanezumab at an 8 week interval Drug: Placebo for naproxen Oral placebo for naproxen twice a day for 16 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876187

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091012
Study First Received:	April 3, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00876187 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

randomized controlled trial, monoclonal antibody, nerve growth factor, naproxen

Study placed in the following topic categories:

Anti-Inflammatory Agents
Naproxen
Cyclooxygenase Inhibitors
Low Back Pain
Pain
Back Pain
Antibodies, Monoclonal
Signs and Symptoms
Antibodies

Analgesics, Non-Narcotic
Neurologic Manifestations
Mitogens
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Low Back Pain
Enzyme Inhibitors
Pain
Gout Suppressants
Back Pain

Pharmacologic Actions
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009