A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee (ITIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00565812
First received: November 29, 2007
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.


Condition Intervention Phase
Osteoarthritis
Drug: SD-6010
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Radiographic Study to Investigate the Safety and Efficacy of Orally Administered SD-6010 in Subjects With Symptomatic Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessing the progression rate of joint space narrowing in the study knee of subjects diagnosed with knee OA over a 24-month period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessing the safety and tolerability of multiple doses of SD-6010 administered long-term in subjects diagnosed with knee OA; [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Assessing the clinical benefit of multiple doses of SD-6010 in subjects diagnosed with knee OA [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 5077
Study Start Date: November 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 200 mg
High dose active comparator
Drug: SD-6010
200 mg tablets once a day for 2 years
Active Comparator: 50 mg
Low dose active comparator
Drug: SD-6010
50 mg tablets once a day for 2 years
Placebo Comparator: Placebo
Placebo comparator to be used for control purposes
Drug: Placebo
Placebo tablets once a day for 2 years

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2
  • In the past, has been diagnosed with knee OA
  • Radiographic evidence of OA in the study knee

Exclusion Criteria:

  • A diagnosis of any other rheumatic disease
  • Current conditions in the study knee that would confound efficacy
  • Selected, traditional clinical safety and laboratory parameters
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565812

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35209
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Birmingham, Alabama, United States, 35242
United States, Arizona
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85023
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Phoenix, Arizona, United States, 85027
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Tucson, Arizona, United States, 85724
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Carmichael, California, United States, 95608
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Costa Mesa, California, United States, 92627
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Fair Oaks, California, United States, 95628
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Roseville, California, United States, 95661
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Sacramento, California, United States, 95817
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San Diego, California, United States, 92128
United States, Colorado
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Denver, Colorado, United States, 80209
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Golden, Colorado, United States, 80401
United States, Connecticut
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Stamford, Connecticut, United States, 06905
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Trumbull, Connecticut, United States, 06611
United States, Florida
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Gainesville, Florida, United States, 32607
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Gainsville, Florida, United States, 32607
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Jacksonville, Florida, United States, 32216
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Plantation, Florida, United States, 33324
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Plantation, Florida, United States, 33317
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West Palm Beach, Florida, United States, 33407
United States, Georgia
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Woodstock, Georgia, United States, 30189
United States, Hawaii
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Honolulu, Hawaii, United States, 96814
United States, Illinois
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Chicago, Illinois, United States, 60611
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Evanston, Illinois, United States, 60201
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Glenview, Illinois, United States, 60025
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Gurnee, Illinois, United States, 60031
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Morton Grove, Illinois, United States, 60053
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Springfield, Illinois, United States, 62704
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Vernon Hills, Illinois, United States, 60061
United States, Indiana
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Avon, Indiana, United States, 46123
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New Albany, Indiana, United States, 47150
United States, Kansas
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Wichita, Kansas, United States, 67205
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Wichita, Kansas, United States, 67207
United States, Kentucky
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Lexington, Kentucky, United States, 40517
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Louisville, Kentucky, United States, 40213
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Madisonville, Kentucky, United States, 42431
United States, Louisiana
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Shreveport, Louisiana, United States, 71115
United States, Maine
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Portland, Maine, United States, 04102
United States, Maryland
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Rockville, Maryland, United States, 20850
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Wheaton, Maryland, United States, 20902
United States, Massachusetts
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Brockton, Massachusetts, United States, 02301
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Fall River, Massachusetts, United States, 02720
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Fall River, Massachusetts, United States, 02721
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New Bedford, Massachusetts, United States, 02740
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Wellesley Hills, Massachusetts, United States, 02481-2106
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Worcester, Massachusetts, United States, 01605
United States, Michigan
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Cadillac, Michigan, United States, 49601
United States, Mississippi
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Flowood, Mississippi, United States, 39232
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Port Gibson, Mississippi, United States, 39150
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Tupelo, Mississippi, United States, 38801
United States, Missouri
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Chesterfield, Missouri, United States, 63017
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Kansas City, Missouri, United States, 64114
United States, Nevada
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Las Vegas, Nevada, United States, 89117
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Las Vegas, Nevada, United States, 89109
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Las Vegas, Nevada, United States, 89128
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Las Vegas, Nevada, United States, 89118
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Las Vegas, Nevada, United States, 89144
United States, New York
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Endwell, New York, United States, 13760
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New York, New York, United States, 10003
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Rochester, New York, United States, 14625
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Syracuse, New York, United States, 13210
United States, North Carolina
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Burlington, North Carolina, United States, 27215
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Greensboro, North Carolina, United States, 27408
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Greensboro, North Carolina, United States, 27407
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Mooresville, North Carolina, United States, 28117
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Salisbury, North Carolina, United States, 28144
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Statesville, North Carolina, United States, 28625
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Wilmington, North Carolina, United States, 28401
United States, North Dakota
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Fargo, North Dakota, United States, 58103
United States, Ohio
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Beachwood, Ohio, United States, 44122
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Columbus, Ohio, United States, 43213
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Columbus, Ohio, United States, 43235
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
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Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island
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Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
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Charleston, South Carolina, United States, 29407
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Greer, South Carolina, United States, 29651
United States, Tennessee
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Fayetteville, Tennessee, United States, 37334
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Kingsport, Tennessee, United States, 37660
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Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38125
United States, Texas
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Dallas, Texas, United States, 75231
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San Antonio, Texas, United States, 78218
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San Antonio, Texas, United States, 78217
United States, Utah
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Midvale, Utah, United States, 84047
United States, Virginia
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Norfolk, Virginia, United States, 23502
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Richmond, Virginia, United States, 23294
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Virginia Beach, Virginia, United States, 23454
United States, Washington
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Tacoma, Washington, United States, 98405
United States, Wisconsin
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Kenosha, Wisconsin, United States, 53142
Argentina
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Buenos Aires, Argentina, C1425AWC
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Buenos Aires, Argentina, C1013AAR
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Buenos Aires, Argentina, C1034ACO
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Buenos Aires, Argentina, C1114AAH
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Buenos Aires, Argentina, C1405BCH
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Belgium
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Bruxelles, Belgium, 1200
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Leuven, Belgium, 3000
Canada, Alberta
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Edmonton, Alberta, Canada, T5M 0H4
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
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Newmarket, Ontario, Canada, L3Y 3R7
Canada, Quebec
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Sainte-Foy, Quebec, Canada, G1W 4R4
Czech Republic
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Brno, Czech Republic, 656 91
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Brno - Zidenice, Czech Republic, 615 00
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Ceske Budejovice, Czech Republic, 370 01
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Hostivice, Czech Republic, 253 01
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Praha 1, Czech Republic, 11000
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Praha 11 - Chodov, Czech Republic, 148 00
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Praha 2, Czech Republic, 128 50
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Praha 6, Czech Republic, 169 00
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Praha 6, Czech Republic, 162 00
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Zlin, Czech Republic, 760 01
Germany
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Bad Hersfeld, Germany, 36251
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Berlin, Germany, 13125
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Berlin, Germany, 12247
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Deggingen, Germany, 73326
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Schwerin, Germany, 19055
Hungary
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Budapest, Hungary, H-1036
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Budapest, Hungary, 1126
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Eger, Hungary, 3300
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Gyula, Hungary, 5700
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Komarom, Hungary, 2900
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Szolnok, Hungary, H-5000
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Veszprem, Hungary, H-8200
Italy
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Arenzano, Italy, 16011
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Jesi (Ancona), Italy, 60035
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Milano, Italy, 20157
Peru
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Santiago de Surco, Lima, Peru, Lima 33
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Callao, Peru, Callao-02
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Lima, Peru, L-11
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Lima, Peru, L-29
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Lima, Peru, L-27
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Lima, Peru, Lima-27
Poland
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Cieszyn, Poland, 43-400
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Wroclaw, Poland, 50-088
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Wroclaw, Poland, 50-556
Russian Federation
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Moscow, Russian Federation, 115522
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Moscow, Russian Federation, 115093
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St. Petersburg, Russian Federation, 194291
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St. Petersburg, Russian Federation, 193312
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St. Petersburg, Russian Federation, 195427
Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia, 826 06
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Piestany, Slovakia, 921 12
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15705
Pfizer Investigational Site
Guadalajara, Spain, 19002
Pfizer Investigational Site
Sevilla, Spain, 41014
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00565812     History of Changes
Other Study ID Numbers: A6171016
Study First Received: November 29, 2007
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
knee Osteoarthritis Disease Modifying Osteoarthritis Drug

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014