Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
NCT02697773
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
877-355-2010
- Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
- Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids
- Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline
- Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol
- Women able to have children must agree to use 2 forms of contraception during the study
- Body Mass Index (BMI) greater than 39
- History of diseases other than osteoarthritis in a shoulder, hip or knee (example,
rheumatoid arthritis, gout, joint infections, osteonecrosis)
- Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or
certain types of fractures
- Patients who have had significant trauma or surgery to a knee, hip or shoulder within
the previous year
- Planned surgical procedure during the study
- Patients who are largely or wholly incapacitated (example bedridden or confined to a
wheelchair, permitting little or no self-care)
- Patients who would be unwilling or unable to undergo joint replacement surgery if one
eventually became necessary
- Patients with significant conditions other than osteoarthritis that could interfere
with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
- Patients with significant heart, neurological or psychiatric diseases
- Patients who had cancer other than certain skin cancers within the past 5 years
- Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2
years
- Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed
during the course of the study.
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
- Huntsville, Alabama
- Peoria, Arizona
- Phoenix, Arizona
- Anaheim, California
- Huntington Beach, California
- Long Beach, California
- Orange, California
- Paramount, California
- Stockton, California
- Tustin, California
- Walnut Creek, California
- Whittier, California
- Wheatridge, Colorado
- Danbury, Connecticut
- New Milford, Connecticut
- Waterbury, Connecticut
- Ocala, Florida
- Palm Harbor, Florida
- South Miami, Florida
- Tampa, Florida
- Zephyrhills, Florida
- Decatur, Georgia
- Springfield, Illinois
- Dubuque, Iowa
- Dubuque, Iowa
- Lexington, Kentucky
- Madisonville, Kentucky
- Baltimore, Maryland
- Clinton, Maryland
- Frederick, Maryland
- Greenbelt, Maryland
- Wheaton, Maryland
- Brockton, Massachusetts
- Jefferson City, Missouri
- Jefferson City, Missouri
- Springfield, Missouri
- Lincoln, Nebraska
- Omaha, Nebraska
- Las Vegas, Nevada
- Las Vegas, Nevada
- Great Neck, New York
- Manlius, New York
- Mineola, New York
- New York, New York
- Rochester, New York
- Winston Salem, North Carolina
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Zanesville, Ohio
- Eugene, Oregon
- Beaver, Pennsylvania
- Camp Hill, Pennsylvania
- Duncansville, Pennsylvania
- Johnstown, Pennsylvania
- Philadephia, Pennsylvania
- Johnson City, Tennessee
- Knoxville, Tennessee
- New Tazewell, Tennessee
- Dallas, Texas
- Dallas, Texas
- Arlington, Virginia
- Renton, Washington
- Tacoma, Washington
- Yakima, Washington
- Yakima, Washington
- Milwaukee, Wisconsin
- Ham,
- Liege,
- Porto Alegre, RS
- Porto Alegre, RS
- Campinas, SP
- São Paulo, SP
- Calgary, Alberta
- Vancouver, British Columbia
- St. John's, Newfoundland and Labrador
- St. John's, Newfoundland and Labrador
- St. John's, Newfoundland and Labrador
- Corunna, Ontario
- Hamilton, Ontario
- London, Ontario
- Newmarket, Ontario
- North York, Ontario
- Sarnia, Ontario
- Toronto, Ontario
- Windsor, Ontario
- Charlottetown, Prince Edward Island
- Montague, Prince Edward Island
- Mirabel, Quebec
- Montreal, Quebec
- Rimouski, Quebec
- Sherbrooke, Quebec
- Ste-Foy, Quebec
- Saskatoon, Saskatchewan
- Santiago, RM
- Viña Del Mar, V Region
- Rancagua, VI Región
- Bogota, Cundinamarca
- Barranquila,
- Bogota,
- Bucaramanga,
- Joue Les Tours,
- L'Union,
- Poitiers,
- Tours,
- Randalstown, Co Antrim
- Newtownabbey, Co.Antrim
- Leslie, Fife
- Watford, Herts
- Canterbury, Kent
- Wigan, Lancs
- Bradwell Common, Milton Keynes
- Greenisland, Carrickfergus, Northern Ireland
- Barry, Vale of Glamorgan
- Pound Hill, Crawley, West Sussex
- Bradford on Avon, Wiltshire
- Midsomer Norton, Wiltshire
- Bangor,
- Bath,
- Belfast,
- Blackpool,
- Cardiff,
- Cookstown,
- Trowbridge,
- Birmingham, Alabama
- Birmingham, Alabama
- Phoenix, Arizona
- Surprise, Arizona
- Tucson, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Anaheim, California
- Covina, California
- Fullerton, California
- Irvine, California
- Irvine, California
- North Hollywood, California
- San Diego, California
- San Diego, California
- Upland, California
- Boulder, Colorado
- Bridgeport, Connecticut
- Stamford, Connecticut
- Fort Myers, Florida
- Hialeah, Florida
- Miami, Florida
- Miami, Florida
- Miami, Florida
- Orlando, Florida
- Ormond Beach, Florida
- Tamarac, Florida
- The Villages, Florida
- Atlanta, Georgia
- Gainesville, Georgia
- Honolulu, Hawaii
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Brownsburg, Indiana
- West Des Moines, Iowa
- Wichita, Kansas
- New Orleans, Louisiana
- North Attleboro, Massachusetts
- Rochester Hills, Michigan
- Flowood, Mississippi
- Las Vegas, Nevada
- Freehold, New Jersey
- Albuquerque, New Mexico
- Hartsdale, New York
- Raleigh, North Carolina
- Fargo, North Dakota
- Franklin, Ohio
- Tiffin, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- State College, Pennsylvania
- Greenville, South Carolina
- Rapid City, South Dakota
- Nashville, Tennessee
- Arlington, Texas
- Austin, Texas
- Baytown, Texas
- Dallas, Texas
- Fort Worth, Texas
- Houston, Texas
- Houston, Texas
- Plano, Texas
- Chesapeake, Virginia
- Danville, Virginia
- Richmond, Virginia
- Bellevue, Washington
- Brampton, Ontario
- Burlington, Ontario
- Guelph, Ontario
- Hamilton, Ontario
- Kitchener, Ontario
- London, Ontario
- Mississauga, Ontario
- Oakville, Ontario
- Oshawa, Ontario
- Sarnia, Ontario
- Montreal, Quebec
- Quebec City, Quebec
- Sherbrooke, Quebec
- Quebec,
- Quebec,
- Quebec,
- Quebec,
- Ponce,
- San Juan,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee | ||||||
Official Title ICMJE | A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF A DOSE TITRATION REGIMEN FOR THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE | ||||||
Brief Summary | The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE |
| ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * |
| ||||||
* 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 | 698 | ||||||
Original Estimated Enrollment ICMJE | 690 | ||||||
Actual Study Completion Date ICMJE | May 14, 2018 | ||||||
Actual Primary Completion Date | December 5, 2017 (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 | Canada, Puerto Rico, United States | ||||||
Removed Location Countries | Belgium | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02697773 | ||||||
Other Study ID Numbers ICMJE | A4091056 2013-002222-23 ( EudraCT Number ) OA TITRATION STUDY ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
| ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | March 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |