A Study of Tanezumab in Adults With Chronic Low Back Pain

NCT00876187

Last updated date
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Pfizer Clinical Trials Contact Center

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[email protected]

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  81. Bethlehem, Pennsylvania
  82. Bridgeville, Pennsylvania
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  84. Philadelphia, Pennsylvania
  85. Cranston, Rhode Island
  86. Warwick, Rhode Island
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  88. Greer, South Carolina
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  90. Germantown, Tennessee
  91. Johnson City, Tennessee
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  94. Beaumont, Texas
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Advanced Information
Descriptive Information
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
  • 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
  • Biological: Tanezumab 10 mg IV
    2 IV administrations of tanezumab 10 mg at an 8 week interval
  • Biological: Tanezumab 5 mg IV
    2 IV administrations of tanezumab 5 mg at an 8 week interval
  • 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
Study Arms  ICMJE
  • Experimental: Tanezumab 20 mg IV
    Interventions:
    • Biological: Tanezumab 20 mg IV
    • Drug: Placebo for naproxen
  • Experimental: Tanezumab 10 mg IV
    Interventions:
    • Biological: Tanezumab 10 mg IV
    • Drug: Placebo for naproxen
  • Experimental: Tanezumab 5 mg IV
    Interventions:
    • Biological: Tanezumab 5 mg IV
    • Drug: Placebo for naproxen
  • Active Comparator: Naproxen
    Interventions:
    • Biological: Placebo for tanezumab
    • Drug: Naproxen
  • Placebo Comparator: Placebo
    Interventions:
    • Biological: Placebo for tanezumab
    • Drug: Placebo for naproxen
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
 (submitted: August 16, 2010)
1359
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2009)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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