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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00565812
First received: November 29, 2007
Last updated: February 20, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565812
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35209 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35242 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Peoria, Arizona, United States, 85381 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85023 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85027 | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pfizer Investigational Site | |
| Carmichael, California, United States, 95608 | |
| Pfizer Investigational Site | |
| Costa Mesa, California, United States, 92627 | |
| Pfizer Investigational Site | |
| Fair Oaks, California, United States, 95628 | |
| Pfizer Investigational Site | |
| Roseville, California, United States, 95661 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95817 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92128 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80209 | |
| Pfizer Investigational Site | |
| Golden, Colorado, United States, 80401 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Stamford, Connecticut, United States, 06905 | |
| Pfizer Investigational Site | |
| Trumbull, Connecticut, United States, 06611 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Gainesville, Florida, United States, 32607 | |
| Pfizer Investigational Site | |
| Gainsville, Florida, United States, 32607 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Plantation, Florida, United States, 33317 | |
| Pfizer Investigational Site | |
| Plantation, Florida, United States, 33324 | |
| Pfizer Investigational Site | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Woodstock, Georgia, United States, 30189 | |
| United States, Hawaii | |
| Pfizer Investigational Site | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| Pfizer Investigational Site | |
| Evanston, Illinois, United States, 60201 | |
| Pfizer Investigational Site | |
| Glenview, Illinois, United States, 60025 | |
| Pfizer Investigational Site | |
| Gurnee, Illinois, United States, 60031 | |
| Pfizer Investigational Site | |
| Morton Grove, Illinois, United States, 60053 | |
| Pfizer Investigational Site | |
| Springfield, Illinois, United States, 62704 | |
| Pfizer Investigational Site | |
| Vernon Hills, Illinois, United States, 60061 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Avon, Indiana, United States, 46123 | |
| Pfizer Investigational Site | |
| New Albany, Indiana, United States, 47150 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67205 | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40517 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40213 | |
| Pfizer Investigational Site | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71115 | |
| United States, Maine | |
| Pfizer Investigational Site | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Rockville, Maryland, United States, 20850 | |
| Pfizer Investigational Site | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Brockton, Massachusetts, United States, 02301 | |
| Pfizer Investigational Site | |
| Fall River, Massachusetts, United States, 02720 | |
| Pfizer Investigational Site | |
| Fall River, Massachusetts, United States, 02721 | |
| Pfizer Investigational Site | |
| New Bedford, Massachusetts, United States, 02740 | |
| Pfizer Investigational Site | |
| Wellesley Hills, Massachusetts, United States, 02481-2106 | |
| Pfizer Investigational Site | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Cadillac, Michigan, United States, 49601 | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Flowood, Mississippi, United States, 39232 | |
| Pfizer Investigational Site | |
| Port Gibson, Mississippi, United States, 39150 | |
| Pfizer Investigational Site | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Chesterfield, Missouri, United States, 63017 | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64114 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89117 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89109 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89144 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89118 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Endwell, New York, United States, 13760 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10003 | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14625 | |
| Pfizer Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Burlington, North Carolina, United States, 27215 | |
| Pfizer Investigational Site | |
| Greensboro, North Carolina, United States, 27408 | |
| Pfizer Investigational Site | |
| Greensboro, North Carolina, United States, 27407 | |
| Pfizer Investigational Site | |
| Mooresville, North Carolina, United States, 28117 | |
| Pfizer Investigational Site | |
| Salisbury, North Carolina, United States, 28144 | |
| Pfizer Investigational Site | |
| Statesville, North Carolina, United States, 28625 | |
| Pfizer Investigational Site | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, North Dakota | |
| Pfizer Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Beachwood, Ohio, United States, 44122 | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43213 | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43235 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29407 | |
| Pfizer Investigational Site | |
| Greer, South Carolina, United States, 29651 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Fayetteville, Tennessee, United States, 37334 | |
| Pfizer Investigational Site | |
| Kingsport, Tennessee, United States, 37660 | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38125 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78217 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78218 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Midvale, Utah, United States, 84047 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| Pfizer Investigational Site | |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Kenosha, Wisconsin, United States, 53142 | |
| Argentina | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1405BCH | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1425AWC | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1013AAR | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1034ACO | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1114AAH | |
| Australia, Tasmania | |
| Pfizer Investigational Site | |
| Hobart, Tasmania, Australia, 7000 | |
| Belgium | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| Pfizer Investigational Site | |
| Leuven, Belgium, 3000 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T5M 0H4 | |
| Canada, Newfoundland and Labrador | |
| Pfizer Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1A 5E8 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Newmarket, Ontario, Canada, L3Y 3R7 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Sainte-Foy, Quebec, Canada, G1W 4R4 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Brno, Czech Republic, 656 91 | |
| Pfizer Investigational Site | |
| Brno - Zidenice, Czech Republic, 615 00 | |
| Pfizer Investigational Site | |
| Ceske Budejovice, Czech Republic, 370 01 | |
| Pfizer Investigational Site | |
| Hostivice, Czech Republic, 253 01 | |
| Pfizer Investigational Site | |
| Praha 1, Czech Republic, 11000 | |
| Pfizer Investigational Site | |
| Praha 11 - Chodov, Czech Republic, 148 00 | |
| Pfizer Investigational Site | |
| Praha 2, Czech Republic, 128 50 | |
| Pfizer Investigational Site | |
| Praha 6, Czech Republic, 162 00 | |
| Pfizer Investigational Site | |
| Praha 6, Czech Republic, 169 00 | |
| Pfizer Investigational Site | |
| Zlin, Czech Republic, 760 01 | |
| Germany | |
| Pfizer Investigational Site | |
| Bad Hersfeld, Germany, 36251 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13125 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 12247 | |
| Pfizer Investigational Site | |
| Deggingen, Germany, 73326 | |
| Pfizer Investigational Site | |
| Schwerin, Germany, 19055 | |
| Hungary | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1126 | |
| Pfizer Investigational Site | |
| Budapest, Hungary, H-1036 | |
| Pfizer Investigational Site | |
| Eger, Hungary, 3300 | |
| Pfizer Investigational Site | |
| Gyula, Hungary, 5700 | |
| Pfizer Investigational Site | |
| Komarom, Hungary, 2900 | |
| Pfizer Investigational Site | |
| Szolnok, Hungary, H-5000 | |
| Pfizer Investigational Site | |
| Veszprem, Hungary, H-8200 | |
| Italy | |
| Pfizer Investigational Site | |
| Arenzano, Italy, 16011 | |
| Pfizer Investigational Site | |
| Jesi (Ancona), Italy, 60035 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20157 | |
| Peru | |
| Pfizer Investigational Site | |
| Santiago de Surco, Lima, Peru, Lima 33 | |
| Pfizer Investigational Site | |
| Callao, Peru, Callao-02 | |
| Pfizer Investigational Site | |
| Lima, Peru, L-11 | |
| Pfizer Investigational Site | |
| Lima, Peru, Lima-27 | |
| Pfizer Investigational Site | |
| Lima, Peru, L-27 | |
| Pfizer Investigational Site | |
| Lima, Peru, L-29 | |
| Poland | |
| Pfizer Investigational Site | |
| Cieszyn, Poland, 43-400 | |
| Pfizer Investigational Site | |
| Wroclaw, Poland, 50-088 | |
| Pfizer Investigational Site | |
| Wroclaw, Poland, 50-556 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115522 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115093 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 194291 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 193312 | |
| Pfizer Investigational Site | |
| St. Petersburg, Russian Federation, 195427 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 826 06 | |
| Pfizer Investigational Site | |
| 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 May 21, 2013