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RN624 In Adult Patients With Chronic Low Back Pain

Last updated on December 16, 2017

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.
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

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

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RN624 In Adult Patients With Chronic Low Back Pain
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • Active Comparator: Naproxen
    Intervention: Drug: Naproxen
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RN624
    Intervention: Drug: PF-04383119 (RN624)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00584870
A4091004
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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