Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

NCT00809354

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.

- Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.

- Pain level and function levels as required by the protocol at Screening and Baseline.

- Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnant women.


- BMI greater than 39.


- Fibromyalgia, regional pain caused by lumbar or cervical compression with
radiculopathy or other moderate to sever pain that may confound assessments or
self-evaluation of the pain associated with OA.


- Signs and symptoms of clinically significant cardiac disease with 6 months prior to
screening.


- Diagnosis of 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 1.7
mg/dL (men) or 1.5 mg/dL (women).


- Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy
within 30 days prior to screening.


- Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Osteoarthritis, ArthritisLong-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
NCT00809354
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Huntsville, Alabama
  5. Mobile, Alabama
  6. Montgomery, Alabama
  7. Chandler, Arizona
  8. Goodyear, Arizona
  9. Green Valley, Arizona
  10. Lake Havasu City, Arizona
  11. Litchfield Park, Arizona
  12. Mesa, Arizona
  13. Paradise Valley, Arizona
  14. Phoenix, Arizona
  15. Sierra Vista, Arizona
  16. Tempe, Arizona
  17. Tucson, Arizona
  18. Tucson, Arizona
  19. Tucson, Arizona
  20. Little Rock, Arkansas
  21. Anaheim, California
  22. Carmichael, California
  23. Chula Vista, California
  24. LA Mesa, California
  25. Lakewood, California
  26. Long Beach, California
  27. Long Beach, California
  28. Los Angeles, California
  29. National City, California
  30. Oceanside, California
  31. Palm Springs, California
  32. Rancho Mirage, California
  33. Sacramento, California
  34. San Diego, California
  35. San Diego, California
  36. San Diego, California
  37. San Francisco, California
  38. San Jose, California
  39. Santa Ana, California
  40. Santa Ana, California
  41. Stockton, California
  42. Westlake Village, California
  43. Colorado Springs, Colorado
  44. Englewood, Colorado
  45. Bridgeport, Connecticut
  46. Trumbull, Connecticut
  47. Lewes, Delaware
  48. Aventura, Florida
  49. Clearwater, Florida
  50. Crystal River, Florida
  51. Cutler Bay, Florida
  52. Daytona Beach, Florida
  53. Dunedin, Florida
  54. Fort Myers, Florida
  55. Hialeah, Florida
  56. Hialeah, Florida
  57. Jacksonville, Florida
  58. Lake Mary, Florida
  59. Miami, Florida
  60. Miami, Florida
  61. Miami, Florida
  62. Naples, Florida
  63. Ocala, Florida
  64. Opalocka, Florida
  65. Orlando, Florida
  66. Palm Harbor, Florida
  67. Pembroke Pines, Florida
  68. Pembroke Pines, Florida
  69. Pinellas Park, Florida
  70. Plantation, Florida
  71. Port Orange, Florida
  72. Sarasota, Florida
  73. Sarasota, Florida
  74. Tampa, Florida
  75. Tampa, Florida
  76. Tampa, Florida
  77. Zephyr Hills, Florida
  78. Atlanta, Georgia
  79. Atlanta, Georgia
  80. Roswell, Georgia
  81. Honolulu, Hawaii
  82. Idaho Falls, Idaho
  83. Idaho Falls, Idaho
  84. Meridian, Idaho
  85. Nampa, Idaho
  86. Chicago, Illinois
  87. Rockford, Illinois
  88. Springfield, Illinois
  89. Vernon Hills, Illinois
  90. Avon, Indiana
  91. Evansville, Indiana
  92. Des Moines, Iowa
  93. West Des Moines, Iowa
  94. Overland Park, Kansas
  95. Elizabethtown, Kentucky
  96. Lexington, Kentucky
  97. Madisonville, Kentucky
  98. Baton Rouge, Louisiana
  99. Oxon Hill, Maryland
  100. Brockton, Massachusetts
  101. Pittsfield, Massachusetts
  102. Watertown, Massachusetts
  103. Bingham Farms, Michigan
  104. Kalamazoo, Michigan
  105. Lansing, Michigan
  106. Lansing, Michigan
  107. Traverse City, Michigan
  108. Biloxi, Mississippi
  109. Olive Branch, Mississippi
  110. Picayune, Mississippi
  111. Florissant, Missouri
  112. Kansas City, Missouri
  113. St Louis, Missouri
  114. St. Louis, Missouri
  115. St. Louis, Missouri
  116. St. Louis, Missouri
  117. Lincoln, Nebraska
  118. Omaha, Nebraska
  119. Edison, New Jersey
  120. Elizabeth, New Jersey
  121. Freehold, New Jersey
  122. Haddon Heights, New Jersey
  123. Passaic, New Jersey
  124. Teaneck, New Jersey
  125. Trenton, New Jersey
  126. Voorhees, New Jersey
  127. Albany, New York
  128. Bronx, New York
  129. Brooklyn, New York
  130. New York, New York
  131. Plainview, New York
  132. West Seneca, New York
  133. Greenville, North Carolina
  134. Hickory, North Carolina
  135. High Point, North Carolina
  136. Raleigh, North Carolina
  137. Salisbury, North Carolina
  138. Fargo, North Dakota
  139. Akron, Ohio
  140. Cincinnati, Ohio
  141. Cincinnati, Ohio
  142. Columbus, Ohio
  143. Columbus, Ohio
  144. Dayton, Ohio
  145. Dayton, Ohio
  146. Dayton, Ohio
  147. Dayton, Ohio
  148. Mayfield Village, Ohio
  149. Middleburg Heights, Ohio
  150. Norman, Oklahoma
  151. Norman, Oklahoma
  152. Oklahoma City, Oklahoma
  153. Oklahoma City, Oklahoma
  154. Oklahoma City, Oklahoma
  155. Tulsa, Oklahoma
  156. Yukon, Oklahoma
  157. Bend, Oregon
  158. Altoona, Pennsylvania
  159. Pittsburgh, Pennsylvania
  160. Warwick, Rhode Island
  161. Columbia, South Carolina
  162. Greer, South Carolina
  163. Rock Hill, South Carolina
  164. Simpsonville, South Carolina
  165. Rapid City, South Dakota
  166. Jackson, Tennessee
  167. Memphis, Tennessee
  168. Abilene, Texas
  169. Austin, Texas
  170. Dallas, Texas
  171. Houston, Texas
  172. Houston, Texas
  173. Houston, Texas
  174. Hurst, Texas
  175. Lubbock, Texas
  176. Mesquite, Texas
  177. New Braunfels, Texas
  178. Pearland, Texas
  179. Plano, Texas
  180. Plano, Texas
  181. San Antonio, Texas
  182. San Antonio, Texas
  183. San Antonio, Texas
  184. Sugar Land, Texas
  185. Temple, Texas
  186. Tomball, Texas
  187. Midvale, Utah
  188. Salt Lake City, Utah
  189. Salt Lake City, Utah
  190. Portsmouth, Virginia
  191. Richmond, Virginia
  192. Roanoke, Virginia
  193. Bellevue, Washington
  194. Tacoma, Washington
  195. Onalaska, Wisconsin
  196. Lunenburg, Nova Scotia
  197. Hamilton, Ontario
  198. Kitchener, Ontario
  199. Newmarket, Ontario
  200. Newmarket, Ontario
  201. St. Catharines, Ontario
  202. Toronto, Ontario
  203. Sherbrooke, Quebec
  204. St. Eustache, Quebec
  205. Trois-Rivieres, Quebec
  206. Quebec,
  207. Quebec,
  208. Barrio Chico, Bogota
  209. Bogota, Cundinamarca
  210. Medellin,
  211. Secunderabad, A.p.
  212. Bangalore, Karnataka
  213. Bangalore, Karnataka
  214. Mangalore, Karnataka
  215. Pune, Maharashtra
  216. Coimbatore, Tamilnadu
  217. Bangalore,
  218. Lucknow,
  219. Daegu,
  220. Incheon,
  221. Seocho-gu Seoul,
  222. Seoul,
  223. Seoul,
  224. Leon Gto, Guanajuato
  225. Coahuila,
  226. Culiacan Sinaloa,
  227. Jalisco,
  228. Amsterdam,
  229. Nijmegen,
  230. Utrecht,
  231. Davao City, Manila
  232. Alabang Muntinlupa City,
  233. Cebu City,
  234. Cebu City,
  235. Davao City,
  236. Manila,
  237. Muntinlupa,
  238. Moscow,
  239. Moscow,
  240. Moscow,
  241. Saint Petersburg,
  242. Saint-Petersburg,
  243. Saint-Petersburg,
  244. Johannesburg, Bryanston
  245. Panorama, Cape Town
  246. Bloemfontein, Free State
  247. Pretoria, Gauteng Province
  248. Benoni, Gauteng
  249. Sydenham, Durban, Kwazulu-natal
  250. Mamelodi East, Pretoria
  251. Cape Town, Western Cape
  252. Parrowvalley, Western Cape
  253. Cape Town,
  254. Durbanville,
  255. Johannesburg,
  256. Kwa-Zulu Natal,
  257. Paarl,
  258. Santiago de Compostela, A Coruña
  259. Barcelona, Sabadell
  260. Barakaldo, Vizcaya
  261. A Coruna,
  262. Barcelona,
  263. Madrid,
  264. Santiago de Compostela,
  265. Sevilla,
  266. Chernivtsi,
  267. Donetsk,
  268. Donetsk,
  269. Kiev,
  270. Kiev,
  271. Kiev,
  272. Kiev,
  273. Zaporizhzhya,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Blind, Controlled Study Of The Long-Term Analgesic Efficacy And Safety of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Brief Summary The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.
Detailed Description This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
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
  • Osteoarthritis
  • Arthritis
Intervention  ICMJE
  • Drug: NSAID
    IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
  • Biological: tanezumab
    IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
  • Biological: tanezumab
    IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
  • Biological: tanezumab
    IV tanezumab 5 mg every 8 weeks (through Week 48)
  • Drug: NSAID
    Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
  • Biological: tanezumab
    IV tanezumab 10 mg every 8 weeks (through Week 48)
Study Arms  ICMJE
  • Active Comparator: IV Placebo + NSAID
    Oral NSAID
    Intervention: Drug: NSAID
  • Experimental: Tanezumab 5 mg
    IV tanezumab 5 mg every 8 weeks (through Week 48)
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 10 mg
    IV tanezumab 10 mg every 8 weeks (through Week 48)
    Intervention: Biological: tanezumab
  • Experimental: Tanezumab 5 mg + NSAID
    IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
    Interventions:
    • Biological: tanezumab
    • Drug: NSAID
  • Experimental: Tanezumab 10 mg + NSAID
    IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
    Interventions:
    • Biological: tanezumab
    • Drug: NSAID
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 22, 2010)
2720
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
2500
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
  • Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
  • Pain level and function levels as required by the protocol at Screening and Baseline.
  • Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of 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:

  • Pregnant women.
  • BMI greater than 39.
  • Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
  • Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
  • Diagnosis of 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 1.7 mg/dL (men) or 1.5 mg/dL (women).
  • Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
  • Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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,   Colombia,   India,   Korea, Republic of,   Mexico,   Netherlands,   Philippines,   Russian Federation,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT00809354
Other Study ID Numbers  ICMJE A4091025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP