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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00565812




Registration number
NCT00565812
Ethics application status
Date submitted
29/11/2007
Date registered
30/11/2007
Date last updated
30/12/2016

Titles & IDs
Public title
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Scientific 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
Secondary ID [1] 0 0
2007-001457-26
Secondary ID [2] 0 0
A6171016
Universal Trial Number (UTN)
Trial acronym
ITIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SD-6010
Treatment: Drugs - SD-6010
Treatment: Drugs - Placebo

Active comparator: 200 mg - High dose active comparator

Active comparator: 50 mg - Low dose active comparator

Placebo comparator: Placebo - Placebo comparator to be used for control purposes


Treatment: Drugs: SD-6010
200 mg tablets once a day for 2 years

Treatment: Drugs: SD-6010
50 mg tablets once a day for 2 years

Treatment: Drugs: Placebo
Placebo tablets once a day for 2 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Progression of Joint Space Narrowing
Timepoint [1] 0 0
Baseline up to Month 24
Primary outcome [2] 0 0
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2
Timepoint [2] 0 0
Baseline up to Month 24
Primary outcome [3] 0 0
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3
Timepoint [3] 0 0
Baseline up to Month 24
Secondary outcome [1] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Timepoint [1] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [2] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [2] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [3] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [3] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [4] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [4] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [5] 0 0
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Timepoint [5] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [6] 0 0
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Timepoint [6] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [7] 0 0
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Timepoint [7] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [8] 0 0
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Timepoint [8] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [9] 0 0
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Timepoint [9] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [10] 0 0
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [10] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [11] 0 0
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [11] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [12] 0 0
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Timepoint [12] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [13] 0 0
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
Timepoint [13] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [14] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24
Timepoint [14] 0 0
Baseline, Month 12, 24
Secondary outcome [15] 0 0
Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24
Timepoint [15] 0 0
Baseline, Month 12, 24
Secondary outcome [16] 0 0
Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24
Timepoint [16] 0 0
Baseline, Month 12, 24
Secondary outcome [17] 0 0
Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24
Timepoint [17] 0 0
Baseline, Month 12, 24
Secondary outcome [18] 0 0
Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24
Timepoint [18] 0 0
Baseline, Month 12, 24
Secondary outcome [19] 0 0
Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24
Timepoint [19] 0 0
Baseline, Month 12, 24
Secondary outcome [20] 0 0
Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24
Timepoint [20] 0 0
Baseline, Month 12, 24
Secondary outcome [21] 0 0
Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24
Timepoint [21] 0 0
Baseline, Month 12, 24
Secondary outcome [22] 0 0
Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24
Timepoint [22] 0 0
Baseline, Month 12, 24
Secondary outcome [23] 0 0
Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24
Timepoint [23] 0 0
Baseline, Month 12, 24
Secondary outcome [24] 0 0
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Timepoint [24] 0 0
Baseline, Month 12, 24
Secondary outcome [25] 0 0
Number of Participants With EuroQoL-5D Self-Care Domain Score
Timepoint [25] 0 0
Baseline, Month 12, 24
Secondary outcome [26] 0 0
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Timepoint [26] 0 0
Baseline, Month 12, 24
Secondary outcome [27] 0 0
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Timepoint [27] 0 0
Baseline, Month 12, 24
Secondary outcome [28] 0 0
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Timepoint [28] 0 0
Baseline, Month 12, 24
Secondary outcome [29] 0 0
EuroQoL-5D Visual Analog Scale Score
Timepoint [29] 0 0
Baseline, Month 12, 24
Secondary outcome [30] 0 0
Number of Participants With Increase in Total Analgesic Medication Use
Timepoint [30] 0 0
Month 12, 24
Secondary outcome [31] 0 0
Number of Participants With Decrease in Total Analgesic Medication Use
Timepoint [31] 0 0
Month 12, 24
Secondary outcome [32] 0 0
Patient Global Impression of Change Score
Timepoint [32] 0 0
Month 24
Secondary outcome [33] 0 0
Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Timepoint [33] 0 0
Month 24
Secondary outcome [34] 0 0
Number of Participants With Joint Space Narrowing Progression
Timepoint [34] 0 0
Month 24
Secondary outcome [35] 0 0
Number of Participants Applicable for Virtual Joint Replacement
Timepoint [35] 0 0
Month 24

Eligibility
Key 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
Minimum age
40 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
1457
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Menzies Research Institute - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Leuven
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
Newfoundland and Labrador
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Brno - Zidenice
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Brno
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Ceske Budejovice
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Hostivice
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Praha 11 - Chodov
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Praha 1
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Praha 2
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Praha 6
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Zlin
Country [51] 0 0
Germany
State/province [51] 0 0
Bad Hersfeld
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Deggingen
Country [54] 0 0
Germany
State/province [54] 0 0
Schwerin
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Eger
Country [57] 0 0
Hungary
State/province [57] 0 0
Gyula
Country [58] 0 0
Hungary
State/province [58] 0 0
Komarom
Country [59] 0 0
Hungary
State/province [59] 0 0
Szolnok
Country [60] 0 0
Hungary
State/province [60] 0 0
Veszprem
Country [61] 0 0
Italy
State/province [61] 0 0
Arenzano
Country [62] 0 0
Italy
State/province [62] 0 0
Jesi (Ancona)
Country [63] 0 0
Italy
State/province [63] 0 0
Milano
Country [64] 0 0
Peru
State/province [64] 0 0
Lima
Country [65] 0 0
Peru
State/province [65] 0 0
Callao
Country [66] 0 0
Poland
State/province [66] 0 0
Cieszyn
Country [67] 0 0
Poland
State/province [67] 0 0
Wroclaw
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Moscow
Country [69] 0 0
Russian Federation
State/province [69] 0 0
St. Petersburg
Country [70] 0 0
Slovakia
State/province [70] 0 0
Bratislava
Country [71] 0 0
Slovakia
State/province [71] 0 0
Piestany
Country [72] 0 0
Spain
State/province [72] 0 0
A Coruña
Country [73] 0 0
Spain
State/province [73] 0 0
Guadalajara
Country [74] 0 0
Spain
State/province [74] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00565812