RN624 In Adult Patients With Chronic Low Back Pain

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NCT00584870

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Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

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1-800-718-1021

By email

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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

- 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.
Show details


- 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

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE RN624 In Adult Patients With Chronic Low Back Pain
Official Title  ICMJE Phase II Randomized, Double-Blind, Placebo And Active Controlled, Multicenter, Parallel Group Proof Of Concept Study Of The Analgesic Effects Of RN624 In Adult Patients With Chronic Low Back Pain
Brief Summary The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Naproxen
    Oral naproxen 500 mg twice daily for Weeks 1-12.
  • Drug: Placebo
    Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.
  • Drug: PF-04383119 (RN624)
    Single IV infusion of 200 micrograms/kg RN624 on Day 1
Study Arms  ICMJE
  • Active Comparator: Naproxen
    Intervention: Drug: Naproxen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RN624
    Intervention: Drug: PF-04383119 (RN624)
Publications * Not Provided

*   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: October 16, 2008)		225
Original Enrollment  ICMJE
 (submitted: December 21, 2007)		275
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

  • 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
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 NCT00584870
Other Study ID Numbers  ICMJE A4091004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials 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 October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP