Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
CompletedPhase 3NCT02528188
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.
Study details
- Official title
- A Phase 3 Randomized, Double-Blind, Active-Controlled, Multicenter Study Of The Long-Term Safety And Efficacy Of Subcutaneous Administration Of Tanezumab In Subjects With Osteoarthritis Of The Hip Or Knee
- Interventions
- Drug: NSAID
- Biological: Tanezumab 2.5 mg
- Biological: Tanezumab 5 mg
- Sponsor
- Pfizer
- Start date
- 2015-07-21
- Primary completion
- 2018-10-05
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia, Brazil, Bulgaria, Colombia, Croatia, Japan, Lithuania, Mexico, New Zealand, Peru, Philippines, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine, United States
- Total sites listed
- 507
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader * Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period * WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening * Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study * Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements Exclusion Criteria: * Subjects exceeding protocol defined BMI or body weight limits * History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments * Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer * A history of osteonecrosis or osteoporotic fracture * History of significant trauma or surgery to a knee, hip or shoulder within the previous year * Planned surgical procedure during the duration of the study * Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain * Signs or symptoms of carpal tunnel syndrome in the year prior to Screening * Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required * Contraindications to magnetic resonance imaging * History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAI…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02528188