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RN624 In Adult Patients With Chronic Low Back Pain

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
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.
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- Male or female of any race, >18 years of age and have BMI ≤39 kg/m2

- Present with duration of chronic low back pain of ≥3 months requiring regular use of
analgesic medication (>4 days per week for the past month)

- Primary location of low back pain is between the 12th thoracic vertebra and the lower
gluteal folds, with or without radiation into the posterior thigh, classified as
Category 1 or 2 according to the classification of the Quebec Task Force in Spinal
Disorders

- Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment
at Screening, and completes at least 4 daily pain diaries during the 5 days prior to
Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent
major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)

- History of lumbosacral radiculopathy, spinal stenosis associated with neurological
impairment, or neurogenic claudication

- Osteoporotic compression fracture within the last 6 months

- Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e.,
ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel
disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia;
Tumors or infections of the spinal cord

- Patients receiving acetaminophen only to manage their chronic low back pain

- Any uncontrolled or untreated chronic disease

NCT00584870
Pfizer
Completed
RN624 In Adult Patients With Chronic Low Back Pain

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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