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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: November 1, 2016
Last verified: November 2016
Results First Received: June 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Drug: SD-6010
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 5077 participants were screened in the study, out of which only 1457 participants were randomized.

Reporting Groups
  Description
SD-6010 50 Milligram (mg) Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
SD-6010 200 mg Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
Placebo Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.

Participant Flow:   Overall Study
    SD-6010 50 Milligram (mg)   SD-6010 200 mg   Placebo
STARTED   485   486   486 
COMPLETED   341   351   356 
NOT COMPLETED   144   135   130 
Death                2                1                3 
Did not Meet Entrance Criteria                1                0                1 
Lost to Follow-up                10                8                8 
Withdrawal by Subject                58                47                48 
Work Schedule                5                3                1 
Protocol Violation                2                6                4 
Adverse Event                41                54                40 
Jury Duty                1                0                0 
Relocated Out of Area                5                8                9 
Sponsor Decision                1                5                1 
Domestic Reasons                7                1                3 
Research Site Closure                6                1                8 
Surgical Intervention                0                1                2 
Low Compliance                1                0                1 
Follow-up Visit Not Completed                2                0                1 
Physician Decision                2                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all participants randomized to the study.

Reporting Groups
  Description
SD-6010 50 Milligram (mg) Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
SD-6010 200 mg Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
Placebo Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
Total Total of all reporting groups

Baseline Measures
   SD-6010 50 Milligram (mg)   SD-6010 200 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 485   486   486   1457 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.0  (8.7)   60.8  (8.6)   61.3  (9.1)   61.0  (8.8) 
Gender 
[Units: Participants]
Count of Participants
       
Female      383  79.0%      367  75.5%      364  74.9%      1114  76.5% 
Male      102  21.0%      119  24.5%      122  25.1%      343  23.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Progression of Joint Space Narrowing   [ Time Frame: Baseline up to Month 24 ]

2.  Primary:   Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2   [ Time Frame: Baseline up to Month 24 ]

3.  Primary:   Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3   [ Time Frame: Baseline up to Month 24 ]

4.  Secondary:   Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

5.  Secondary:   Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

6.  Secondary:   Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

7.  Secondary:   Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

8.  Secondary:   Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

9.  Secondary:   Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

10.  Secondary:   Change From Baseline in Physician’s Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

11.  Secondary:   Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

12.  Secondary:   Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

13.  Secondary:   Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

14.  Secondary:   Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

15.  Secondary:   Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

16.  Secondary:   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   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

17.  Secondary:   Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

18.  Secondary:   Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

19.  Secondary:   Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

20.  Secondary:   Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

21.  Secondary:   Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

22.  Secondary:   Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

23.  Secondary:   Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

24.  Secondary:   Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

25.  Secondary:   Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

26.  Secondary:   Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24   [ Time Frame: Baseline, Month 12, 24 ]

27.  Secondary:   Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score   [ Time Frame: Baseline, Month 12, 24 ]

28.  Secondary:   Number of Participants With EuroQoL-5D Self-Care Domain Score   [ Time Frame: Baseline, Month 12, 24 ]

29.  Secondary:   Number of Participants With EuroQoL-5D Usual Activity Domain Score   [ Time Frame: Baseline, Month 12, 24 ]

30.  Secondary:   Number of Participants With EuroQo-5D Pain and Discomfort Domain Score   [ Time Frame: Baseline, Month 12, 24 ]

31.  Secondary:   Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score   [ Time Frame: Baseline, Month 12, 24 ]

32.  Secondary:   EuroQoL-5D Visual Analog Scale Score   [ Time Frame: Baseline, Month 12, 24 ]

33.  Secondary:   Number of Participants With Increase in Total Analgesic Medication Use   [ Time Frame: Month 12, 24 ]

34.  Secondary:   Number of Participants With Decrease in Total Analgesic Medication Use   [ Time Frame: Month 12, 24 ]

35.  Secondary:   Patient Global Impression of Change Score   [ Time Frame: Month 24 ]

36.  Secondary:   Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index   [ Time Frame: Month 24 ]

37.  Secondary:   Number of Participants With Joint Space Narrowing Progression   [ Time Frame: Month 24 ]

38.  Secondary:   Number of Participants Applicable for Virtual Joint Replacement   [ Time Frame: Month 24 ]

39.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 7-10 days after last dose of study drug (Week 111) ]

40.  Other Pre-specified:   Number of Participants With Electrocardiogram (ECG) Abnormalities   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]

41.  Other Pre-specified:   Number of Participants With Laboratory Test Abnormalities   [ Time Frame: Baseline up to Week 111 ]

42.  Other Pre-specified:   Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96   [ Time Frame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96 ]

43.  Other Pre-specified:   Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96   [ Time Frame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96 ]

44.  Other Pre-specified:   Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96   [ Time Frame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00565812     History of Changes
Other Study ID Numbers: A6171016
2007-001457-26 ( EudraCT Number )
ITIC ( Other Identifier: Alias Study Number )
Study First Received: November 29, 2007
Results First Received: June 22, 2016
Last Updated: November 1, 2016