ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Funabashi-shi, Chiba
- Funabashi, Chiba
- Matsudo-shi, Chiba
- Fukuoka-shi, Fukuoka
- Chitose, Hokkaido
- Sapporo-shi, Hokkaido
- Sapporo, Hokkaido
- Katougun, Hyogo
- Kobe, Hyogo
- Nishinomiya, Hyogo
- Sagamihara-shi, Kanagawa
- Yokohama-shi, Kanagawa
- Yokohama, Kanagawa
- Hatogaya-shi, Saitama
- Kumagaya-shi, Saitama
- Kumagayashi, Saitama
- Minamisaitama-gun, Saitama
- Saitama-shi, Saitama
- Tokorozawa, Saitama
- Adachi-Ku, Tokyo
- Bunkyou-ku, Tokyo
- Edogawa-ku, Tokyo
- Itabashi-ku, Tokyo
- Koito-ku, Tokyo
- Meguro-Ku, Tokyo
- Nakano-ku, Tokyo
- Nerima-ku, Tokyo
- Ota-Ku, Tokyo
- Ota-Ku, Tokyo
- Setagaya-ku, Tokyo
- Shibuya-ku, Tokyo
- Shinagawa-ku, Tokyo
- Shinjyuku-ku, Tokyo
- Suginami-ku, Tokyo
- Sumida-ku, Tokyo
- Toyoshima-ku, Tokyo
- Chiba,
- Fukuoka,
- Fukuoka,
- Tokyo,
- Anniston, Alabama
- Hueytown, Alabama
- Huntsville, Alabama
- Mobile, Alabama
- Chandler, Arizona
- Peoria, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Tempe, Arizona
- Tempe, Arizona
- Little Rock, Arkansas
- Burbank, California
- Fresno, California
- Garden Grove, California
- La Jolla, California
- Los Gatos, California
- Oceanside, California
- Rancho Mirage, California
- Roseville, California
- Sacramento, California
- San Diego, California
- Upland, California
- Windomar, California
- Boulder, Colorado
- Colorado Springs, Colorado
- Stamford, Connecticut
- Trumbull, Connecticut
- Chiefland, Florida
- DeFuniak Springs, Florida
- DeLand, Florida
- Jacksonville, Florida
- Naples, Florida
- Orlando, Florida
- Pembroke Pines, Florida
- Pinellas Park, Florida
- South Miami, Florida
- St. Petersburg, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Blue Ridge, Georgia
- Marietta, Georgia
- Boise, Idaho
- Evansville, Indiana
- Prairie Village, Kansas
- Topeka, Kansas
- Lexington, Kentucky
- Madisonville, Kentucky
- Monroe, Louisiana
- Baltimore, Maryland
- Worcester, Massachusetts
- Biloxi, Mississippi
- Jackson, Mississippi
- Springfield, Missouri
- St. Louis, Missouri
- St. Louis, Missouri
- Omaha, Nebraska
- Omaha, Nebraska
- Las Vegas,, Nevada
- Las Vegas, Nevada
- Berlin, New Jersey
- Willingboro, New Jersey
- Albuquerque, New Mexico
- Manlius, New York
- New York, New York
- New York, New York
- Rochester, New York
- Rochester, New York
- Williamsville, New York
- Greensboro, North Carolina
- Lenoir, North Carolina
- Raleigh, North Carolina
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Medford, Oregon
- Portland, Oregon
- Altoona, Pennsylvania
- Bridgeville, Pennsylvania
- Duncansville, Pennsylvania
- Philadelphia, Pennsylvania
- Cranston, Rhode Island
- Warwick, Rhode Island
- Columbia, South Carolina
- Greer, South Carolina
- Rapid City, South Dakota
- Germantown, Tennessee
- Johnson City, Tennessee
- Austin, Texas
- Beaumont, Texas
- Beaumont, Texas
- Bryan, Texas
- Carroltown, Texas
- Dallas, Texas
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Nassau Bay, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Salt Lake City, Utah
- Charlottesville, Virginia
- Norfolk, Virginia
- Richmond, Virginia
- Virginia Beach, Virginia
- Bellevue, Washington
- Bs. As.,
- Buenos Aires,
- Goiania, Goias
- Curitiba, Parana
- Curitiba, PR
- Petropolis, Rio de Janeiro
- Sao Paulo, SP
- Sao Paulo, SP
- Sao Paulo, SP
- Sao Paulo,
- Santiago,
- Bogota, D.c.
- Bogota D.c,
- Cali-valle,
- Cartago City, Cartago
- Hatillo, San Jose
- Quito, Pichincha
- Toluca, Edo. de Mexico
- Zapopan, Jalisco
- Zapopan, Jalisco
- Puebla,
- Puebla,
- Puebla,
- Lima,
- Lima,
- Caracas, DF
- Caracas, DF
- Caracas, DF
- Caracas,
- Anniston, Alabama
- Hueytown, Alabama
- Mobile, Alabama
- Chandler, Arizona
- Peoria, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Tempe, Arizona
- Tempe, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Burbank, California
- Fresno, California
- Garden Grove, California
- La Jolla, California
- Los Gatos, California
- Oceanside, California
- Rancho Mirage, California
- Roseville, California
- Sacramento, California
- San Diego, California
- Upland, California
- Windomar, California
- Stamford, Connecticut
- Trumbull, Connecticut
- Chiefland, Florida
- DeFuniak Springs, Florida
- DeLand, Florida
- Fort Lauderdale, Florida
- Jacksonville, Florida
- Naples, Florida
- Orlando, Florida
- Pembroke Pines, Florida
- Pinellas Park, Florida
- South Miami, Florida
- St. Petersburg, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Blue Ridge, Georgia
- Marietta, Georgia
- Boise, Idaho
- Evansville, Indiana
- Overland Park, Kansas
- Prairie Village, Kansas
- Topeka, Kansas
- Lexington, Kentucky
- Madisonville, Kentucky
- Monroe, Louisiana
- Baltimore, Maryland
- Worcester, Massachusetts
- Lansing, Michigan
- Biloxi, Mississippi
- Jackson, Mississippi
- St. Louis, Missouri
- Omaha, Nebraska
- Omaha, Nebraska
- Las Vagas, Nevada
- Las Vegas, Nevada
- Berlin, New Jersey
- Willingboro, New Jersey
- Albuquerque, New Mexico
- Manlius, New York
- New York, New York
- New York, New York
- Rochester, New York
- Rochester, New York
- Williamsville, New York
- Greensboro, North Carolina
- Lenoir, North Carolina
- Raleigh, North Carolina
- Winston-Salem, North Carolina
- Cincincinati, Ohio
- Cincinnati, Ohio
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Medford, Oregon
- Portland, Oregon
- Altoona, Pennsylvania
- Bethlehem, Pennsylvania
- Bridgeville, Pennsylvania
- Duncansville, Pennsylvania
- Philadelphia, Pennsylvania
- Cranston, Rhode Island
- Warwick, Rhode Island
- Columbia, South Carolina
- Greer, South Carolina
- Rapid City, South Dakota
- Germantown, Tennessee
- Johnson City, Tennessee
- Austin, Texas
- Austin, Texas
- Beaumont, Texas
- Bryan, Texas
- Carroltown, Texas
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Nassau Bay, Texas
- San Antonio, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Salt Lake City, Utah
- Charlottesville, Virginia
- Norfolk, Virginia
- Richmond, Virginia
- Virginia Beach, Virginia
- Bellevue, Washington
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 |
| |||
Study Arms ICMJE |
| |||
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 | 225 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |