A Phase 3 Study of Tanezumab for Chronic Low Back Pain
Launched by PFIZER · Aug 18, 2015
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matchin...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • -Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.
- Exclusion Criteria:
- • --Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.
- • Subjects who have Kellgren Lawrence Grade \> or =2 radiographic evidence of hip or Grade \> or=3 radiographic evidence of knee osteoarthritis will be excluded;
- • History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).
- • History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
- • Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
- • History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
- • Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Boston, Massachusetts, United States
Madrid, , Spain
Rochester, New York, United States
Warwick, Rhode Island, United States
Coral Gables, Florida, United States
Albuquerque, New Mexico, United States
Duncansville, Pennsylvania, United States
Walnut Creek, California, United States
Evansville, Indiana, United States
West Palm Beach, Florida, United States
San Antonio, Texas, United States
Chicago, Illinois, United States
Raleigh, North Carolina, United States
Rochester, New York, United States
Seoul, , Korea, Republic Of
Los Angeles, California, United States
Oklahoma City, Oklahoma, United States
Rochester, New York, United States
New Orleans, Louisiana, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Bay City, Michigan, United States
Wheaton, Maryland, United States
Berlin, New Jersey, United States
Mobile, Alabama, United States
Honolulu, Hawaii, United States
Las Vegas, Nevada, United States
Oklahoma City, Oklahoma, United States
Marietta, Georgia, United States
Spring Valley, California, United States
Houston, Texas, United States
Des Moines, Iowa, United States
Fukushima, , Japan
Saint Petersburg, Florida, United States
Jupiter, Florida, United States
Hallandale Beach, Florida, United States
Toyama, , Japan
Cincinnati, Ohio, United States
Seoul, , Korea, Republic Of
Shinjuku Ku, Tokyo, Japan
Hiroshima, , Japan
Stamford, Connecticut, United States
Olive Branch, Mississippi, United States
Omaha, Nebraska, United States
Houston, Texas, United States
Downingtown, Pennsylvania, United States
Fresno, California, United States
Birmingham, Alabama, United States
Little Rock, Arkansas, United States
North Hollywood, California, United States
Valley Village, California, United States
Denver, Colorado, United States
Boynton Beach, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Woodstock, Georgia, United States
Woodstock, Georgia, United States
Franklin, Ohio, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
Seoul, , Korea, Republic Of
Izumisano, Osaka, Japan
Sacramento, California, United States
Santiago De Compostela, A Coruna, Spain
Denver, Colorado, United States
Chestnut Hill, Massachusetts, United States
Albuquerque, New Mexico, United States
Las Vegas, Nevada, United States
Fargo, North Dakota, United States
Jackson, Mississippi, United States
Blue Ridge, Georgia, United States
New Orleans, Louisiana, United States
Lenoir, North Carolina, United States
Oklahoma City, Oklahoma, United States
Atlantis, Florida, United States
Paris Cedex 14, , France
New York, New York, United States
Wildomar, California, United States
Bellevue, Washington, United States
Chula Vista, California, United States
Watertown, Massachusetts, United States
Saint Louis, Missouri, United States
Trenton, New Jersey, United States
Port Orange, Florida, United States
Newnan, Georgia, United States
Ube, Yamaguchi, Japan
Jackson, Mississippi, United States
Seoul, , Korea, Republic Of
Marietta, Georgia, United States
Toledo, Ohio, United States
Richmond, Virginia, United States
Brownsburg, Indiana, United States
Saitama, , Japan
Arlington, Texas, United States
Phoenix, Arizona, United States
Chicago, Illinois, United States
La Mesa, California, United States
Anaheim, California, United States
Szekszard, , Hungary
Newnan, Georgia, United States
Fort Lauderdale, Florida, United States
Hartsdale, New York, United States
Winston Salem, North Carolina, United States
Jacksonville, Florida, United States
Columbus, Georgia, United States
Midlothian, Virginia, United States
Marlton, New Jersey, United States
West Des Moines, Iowa, United States
Kanazawa, Ishikawa, Japan
Tampa, Florida, United States
Nagakute, Aichi, Japan
Charlottesville, Virginia, United States
Scottsdale, Arizona, United States
Cumberland, Maryland, United States
Sarasota, Florida, United States
Columbia, South Carolina, United States
Las Vegas, Nevada, United States
Oklahoma City, Oklahoma, United States
Quebec, , Canada
Boulder, Colorado, United States
El Cajon, California, United States
San Diego, California, United States
Edgewood, Kentucky, United States
Lake Charles, Louisiana, United States
Bellevue, Washington, United States
Birmingham, Alabama, United States
Alicante, , Spain
Phoenix, Arizona, United States
Chicago, Illinois, United States
Deland, Florida, United States
Quincy, Massachusetts, United States
Valparaiso, Indiana, United States
Miami, Florida, United States
Malaga, , Spain
Bridgeport, Connecticut, United States
Chicago, Illinois, United States
Lafayette, Indiana, United States
Wichita, Kansas, United States
Portsmouth, New Hampshire, United States
Hollywood, Florida, United States
Brooklyn, New York, United States
Draper, Utah, United States
Fresno, California, United States
Long Beach, California, United States
Hakodate, Hokkaido, Japan
Shimonoseki Shi, Yamaguchi, Japan
Szekszard, , Hungary
Mesa, Arizona, United States
Cerritos, California, United States
Garden Grove, California, United States
Montclair, California, United States
Miami, Florida, United States
Miami, Florida, United States
Ocoee, Florida, United States
Gainesville, Georgia, United States
Overland Park, Kansas, United States
Rochester Hills, Michigan, United States
Las Vegas, Nevada, United States
Fargo, North Dakota, United States
Centerville, Ohio, United States
Columbus, Ohio, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States
Funabashi, Chiba, Japan
Himeji, Hyogo, Japan
Kako Gun, Hyogo, Japan
Kobe, Hyogo, Japan
Matsumoto, Nagano, Japan
Fussa, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Fukuoka, , Japan
Fukuoka, , Japan
Mobile, Alabama, United States
Mobile, Alabama, United States
Mobile, Alabama, United States
Saraland, Alabama, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Fresno, California, United States
Los Angeles, California, United States
Milford, Connecticut, United States
Deland, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Lafayette, Indiana, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
West Des Moines, Iowa, United States
Crestview Hills, Kentucky, United States
Edgewood, Kentucky, United States
Bossier City, Louisiana, United States
Bossier City, Louisiana, United States
Troy, Michigan, United States
Wyoming, Michigan, United States
Somerset, New Jersey, United States
Mooresville, North Carolina, United States
Frgi, North Dakota, United States
Beavercreek, Ohio, United States
Mentor, Ohio, United States
Mentor, Ohio, United States
Greer, South Carolina, United States
North Charleston, South Carolina, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Sherbrooke, Quebec, Canada
Quebec, , Canada
Hillerod, , Denmark
Bekescsaba, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Miskolc, , Hungary
Szekszard, , Hungary
Showa Ku, Nagoya, Aichi, Japan
Chuo Ku, Chiba, Chiba, Japan
Ichihara, Chiba, Japan
Wakaba Ku, Chiba, Chiba, Japan
Higashi Ku,Fukuoka, Fukuoka, Japan
Kokuraminami Ku,Kitakyushu, Fukuoka, Japan
Okawa, Fukuoka, Japan
Aizuwakamatsu, Fukushima, Japan
Hakodate, Hokkaido, Japan
Higashinada Ku, Kobe, Hyogo, Japan
Komatsu, Ishikawa, Japan
Beppu, Oita, Japan
Higashiosaka, Osaka, Japan
Suminoe Ku, Osaka, Osaka, Japan
Kumagaya, Saitama, Japan
Hamamatsu, Shizuoka, Japan
Bunkyo Ku, Tokyo, Japan
Minato Ku, Tokyo, Japan
Yonezawa, Yamagata, Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
A Coruna, , Spain
A Coruna, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Malaga, , Spain
Gothenburg, , Sweden
Helsingborg, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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