Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip
NCT ID: NCT00864097
Last Updated: 2021-02-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
607 participants
INTERVENTIONAL
2009-08-11
2010-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tanezumab 10 mg + diclofenac
IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 16)
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
Tanezumab 5 mg + diclofenac
IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 16)
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
Tanezumab 2.5 mg + diclofenac
IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
tanezumab
IV tanezumab 2.5 mg every 8 weeks (through Week 16)
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
IV placebo + diclofenac
IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
IV placebo
IV placebo to match tanezumab every 8 weeks (through Week 16)
Interventions
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tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 16)
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 16)
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
tanezumab
IV tanezumab 2.5 mg every 8 weeks (through Week 16)
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
diclofenac
Oral diclofenac SR 75 mg BID for 32 weeks
IV placebo
IV placebo to match tanezumab every 8 weeks (through Week 16)
Eligibility Criteria
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Inclusion Criteria
* Patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen.
* Pain and function levels as required by the protocol at Screening and Baseline.
* Willing to discontinue all non-study pain medications throughout the study except as permitted per protocol.
* Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria
* BMI greater than 39.
* History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors.
* Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA.
* Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
* Diagnosis or TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
* History, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
* At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 150 micro-mol/L in men or 133 micro-mol/L in women.
* Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening.
* Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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LKH-Medizinische Universitatsklinik Graz
Graz, , Austria
Nuhr Zentrum
Senftenberg, , Austria
ClinPharm International GmbH
Vienna, , Austria
Medizinische Universitaet Wien/AKH
Vienna, , Austria
Rheuma Zentrum Favoriten
Vienna, , Austria
CHU de Nantes
Nantes, , France
Hopital Lariboisiere
Paris, , France
Charité-Universitaetsmedizin Berlin
Berlin, , Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, , Germany
Apotheke
Berlin, , Germany
Herz Apotheke
Bochum, , Germany
Synexus ClinPharm GmbH
Bochum, , Germany
Viereck-Apotheke
Buch, , Germany
Synexus ClinParm GmbH
Dresden, , Germany
Apotheke im Arztehaus Mickten
Dresden, , Germany
Schiller Apotheke & Stadt Apotheke
Göppingen, , Germany
Schmerz- und Palliativzentrum Goeppingen
Göppingen, , Germany
Falken Apotheke Hoheluft
Hamburg, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Klinische Forschung Hannover - Mitte GmbH
Hanover, , Germany
Loewen-Apotheke
Hanover, , Germany
Synexus ClinPharm GmbH
Leipzig, , Germany
Arkana Apotheke OHG
Leipzig, , Germany
Synexus ClinPharm GmbH
Magdeburg, , Germany
Apotheke im MSZ
Magdeburg, , Germany
Apotheke des Ernst von Bergmann Klinikums
Potsdam, , Germany
Synexus ClinParm GmbH
Potsdam, , Germany
Kirchsteig Apotheke
Potsdam, , Germany
"Centrum Medyczne MEDENS S.C. Niepubliczny Zaklad
Chełm Śląski, , Poland
Malopolskie Centrum Medyczne s.c.
Krakow, , Poland
Centrum Medyczne OSTEOMED Sp. z o. o.
Warsaw, , Poland
Synexus SCM Sp. z o.o.
Wroclaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "POLIMEDICA"
Zgierz, , Poland
Municipal Hospital No. 1 "Schuller"
Ploieşti, Prahova, Romania
Clinical Emergency Military Hospital "Dr. Carol Davila"
Bucharest, , Romania
Duo Medical srl
Bucharest, , Romania
Medical Center "SANA"
Bucharest, , Romania
Clinical Hospital "Sf. Maria"
Bucharest, , Romania
Center of Rheumatology "Dr Ion Stoia"
Bucharest, , Romania
Clinical Emergency County Hospital Constanta
Constanța, , Romania
County Emergency Clinic Hospital "Sf. Apostol Andrei"
Galati, , Romania
Center polyclinic of Federal State Institution
Arkhangelsk, , Russia
State Healthcare Institution of Moscow city "City Clinical Hospital #15 n.a. O. M. Filatov"
Moscow, , Russia
Chair of Hospital Therapy of Ryazan State Medical University
Ryazan, , Russia
St. Petersburg State Healthcare Institution "City Hospital #25 City Rheumatology Center"
Saint Petersburg, , Russia
State Educational Institution of Additional Professional Education
Saint Petersburg, , Russia
Institution of Russian Academy of Sciences "St. Petersburg Clinical Hospital of RAS"
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution "City Outpatient Clinical #51"
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution "City Pokrovskaya Hospital"
Saint Petersburg, , Russia
Hospital Nuestra Señora de la Esperanza
Santiago de Compostela, A Coruna, Spain
Centro Salud Petrer 1
Petrel, Alicante, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital Comarcal de Elda
Elda Alicante, , Spain
Hospital Universitario Getafe
Getafe-Madrid, , Spain
Hospital G. U. Gregorio Maranon
Madrid, , Spain
Hospital Clinico Universitario Santiago
Santiago de Compostela, , Spain
Me3plus AB
Gothenburg, , Sweden
Me3plus AB
Gothenburg, , Sweden
Center for Lakemedelsstudier
Malmo, , Sweden
Medicinskt Centrum
Norrköping, , Sweden
Chernivtsi Regional Clinical Hospital,Department of Rheumatology
Chernivtsi, , Ukraine
Road Clinical Hospital at Dnipropetrovsk station, Department of Rheumatology
Dnipropetrovsk, , Ukraine
Institute of Urgent and Recovery Surgery named after V.K. Gusaka AMS Ukraine
Donetsk, , Ukraine
Central City Clinical Hospital#1, Department of Therapy,
Donetsk, , Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
City Clinical Hospital #8, Department of reumatology,
Kharkiv, , Ukraine
State Institution "Institute of Gerontology AMS of Ukraine"
Kiev, , Ukraine
Oleksandrivska Clinical Hospital in Kyiv-Department of Rheumatology # 1
Kyiv, , Ukraine
Kyiv Central Basin Clinical Hospital, Department of cardiology,
Kyiv, , Ukraine
4th City Communal Clinical Hospital, Department of Rheumatology,
Lviv, , Ukraine
City communal clinical hospital #5, Dept. of Therapy, Danylo Galytskiy Lviv National Med. University
Lviv, , Ukraine
Communal Institution Ternopil regional council, "Ternopil Regional Clinical Hospital"
Ternopil, , Ukraine
Vinnytsya regional clinical hospital named after M.I. Pyrogova
Vinnytsia, , Ukraine
Communal institution "City Hospital #7", Department of Therapy,
Zaporizhzhia, , Ukraine
Barnsley Hospital NHS Trust
Barnsley, South Yorkshire, United Kingdom
Department of Rheumatology
Dudley, West Midlands, , United Kingdom
Wrightington Hospital
Wigan, , United Kingdom
Countries
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References
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Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.
Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
Balanescu AR, Feist E, Wolfram G, Davignon I, Smith MD, Brown MT, West CR. Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. Ann Rheum Dis. 2014 Sep;73(9):1665-72. doi: 10.1136/annrheumdis-2012-203164. Epub 2013 Jul 12.
Related Links
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Other Identifiers
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2009-009318-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P3 6 MO OA HIP/KNEE DICLOFENAC
Identifier Type: OTHER
Identifier Source: secondary_id
A4091017
Identifier Type: -
Identifier Source: org_study_id
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