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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:
  • Rate of Progression of Joint Space Narrowing [ Time Frame: Baseline up to Month 24 ]
    Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.

  • 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 ]
    Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.

  • Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3 [ Time Frame: Baseline up to Month 24 ]
    Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.


Secondary Outcome Measures:
  • 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 ]
    The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.

  • 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 ]
    The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.

  • 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 ]
    Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.

  • 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 ]
    The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.

  • 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 ]
    Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.

  • 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 ]
    Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition.

  • 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 ]
    Physician assessed the overall impact of arthritis on the participant's daily life. Participant's condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.

  • 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 ]
    The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.

  • 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 ]
    The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.

  • 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 ]
    The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.

  • 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 ]
    The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.

  • 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 ]
    The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.

  • 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 ]
    The KOOS-PS was used to rate participant's opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.

  • Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.

  • Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.

  • Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.

  • Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.

  • Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.

  • Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.

  • Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.

  • Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.

  • Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.

  • Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24 [ Time Frame: Baseline, Month 12, 24 ]
    The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.

  • Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score [ Time Frame: Baseline, Month 12, 24 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.

  • Number of Participants With EuroQoL-5D Self-Care Domain Score [ Time Frame: Baseline, Month 12, 24 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.

  • Number of Participants With EuroQoL-5D Usual Activity Domain Score [ Time Frame: Baseline, Month 12, 24 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.

  • Number of Participants With EuroQo-5D Pain and Discomfort Domain Score [ Time Frame: Baseline, Month 12, 24 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.

  • Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score [ Time Frame: Baseline, Month 12, 24 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.

  • EuroQoL-5D Visual Analog Scale Score [ Time Frame: Baseline, Month 12, 24 ]
    The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.

  • Number of Participants With Increase in Total Analgesic Medication Use [ Time Frame: Month 12, 24 ]
    Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.

  • Number of Participants With Decrease in Total Analgesic Medication Use [ Time Frame: Month 12, 24 ]
    Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.

  • Patient Global Impression of Change Score [ Time Frame: Month 24 ]
    Patient global impression of change was a participant-rated instrument that measured change in participant's overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.

  • Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index [ Time Frame: Month 24 ]
    The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 [minimum] to 5 [maximum], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.

  • Number of Participants With Joint Space Narrowing Progression [ Time Frame: Month 24 ]
    JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).

  • Number of Participants Applicable for Virtual Joint Replacement [ Time Frame: Month 24 ]
    A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).


Other Outcome Measures:
  • 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) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.

  • Number of Participants With Electrocardiogram (ECG) Abnormalities [ Time Frame: Baseline, Month 3, 6, 12, 18, 24 ]
    Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than [>]140 milliseconds [msec]), junctional/paced rhythm, intraventricular conduction delay (>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.

  • Number of Participants With Laboratory Test Abnormalities [ Time Frame: Baseline up to Week 111 ]
    Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN), platelet: <0.5*LLN or greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil:<0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine:>1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, lipase >1.5*ULN; urine (specific gravity <1.003 or >1.030, pH <4.5 or >8, glucose, ketones, protein, blood/Hgb greater than or equal to [>=]1); pancreatic amylase >1.5*ULN.

  • 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 ]
    Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.

  • 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 ]
    BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.

  • 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 ]

Enrollment: 1457
Study Start Date: November 2007
Study Completion Date: November 2011
Primary Completion Date: October 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 to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Hide Study Locations
Locations
United States, Alabama
Brookwood Internists, P.C.
Birmingham, Alabama, United States, 35209
Greystone Medical Center
Birmingham, Alabama, United States, 35242
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
Arizona Research Center
Phoenix, Arizona, United States, 85023
Pivotal Research Centers
Phoenix, Arizona, United States, 85027
University of Arizona
Tucson, Arizona, United States, 85724
United States, Arkansas
Martin Bowen Hefley Orthopedics
Little Rock, Arkansas, United States, 72205
Teton Research, LLC
Little Rock, Arkansas, United States, 72205
United States, California
Med Center
Carmichael, California, United States, 95608
College Hospital Costa Mesa
Costa Mesa, California, United States, 92627
NeuroNetwork Trials
Costa Mesa, California, United States, 92627
Med Investigations, Inc.
Fair Oaks, California, United States, 95628
Sierra Clinical Research
Roseville, California, United States, 95661
University of California Davis Health System
Sacramento, California, United States, 95817
University of California Davis
Sacramento, California, United States, 95817
Scripps Clinic-Clinical Research
San Diego, California, United States, 92128
Plaza Medical Imaging
Santa Ana, California, United States, 92704
United States, Colorado
Denver Internal Medicine Group
Denver, Colorado, United States, 80209
Mountain View Clinical Research, Inc.
Denver, Colorado, United States, 80209
New West Physicians Clinical Research
Golden, Colorado, United States, 80401
United States, Connecticut
Advanced Radiology Consultants
Fairfield, Connecticut, United States, 06824
Advanced Radiology Consultants
Stamford, Connecticut, United States, 06902
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
New England Research Associates, LLC
Trumbull, Connecticut, United States, 06611
United States, Florida
Southeastern Arthritis Center
Gainesville, Florida, United States, 32607
Southeastern Imaging & Diagnostics
Gainesville, Florida, United States, 32607
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
Gainesville, Florida, United States, 32607
Jacksonville Center for Clincal Research
Jacksonville, Florida, United States, 32216
Memorial Hospital Jacksonville
Jacksonville, Florida, United States, 32216
Gold Coast Research, LLC
Plantation, Florida, United States, 33317
Marin E. Hale, M.D., P.A.
Plantation, Florida, United States, 33317
Sabiha Khan, M.D.
Plantation, Florida, United States, 33324
Kanner, Mendelson, Shteinman, LLC
West Palm Beach, Florida, United States, 33407
Radiant Research
West Palm Beach, Florida, United States, 33407
Rheumatology and Endocrinology Specialists of the Palm Beaches, P.A.
West Palm Beach, Florida, United States, 33407
United States, Georgia
North Georgia Clinical Research
Marietta, Georgia, United States, 30060
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Illinois
Preventive Medicine
Chicago, Illinois, United States, 60611
Rehabilitation Institue of Chicago
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
NorthShore University HealthSystem
Glenview, Illinois, United States, 60025
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States, 60031
Illinois Bone and Joint Institute, LLC
Morton Grove, Illinois, United States, 60053
The Arthritis Center
Springfield, Illinois, United States, 62704
NorthShore University HealthSystem
Vernon Hills, Illinois, United States, 60061
United States, Indiana
Ronald Keith Stegemoller, American Health Network
Avon, Indiana, United States, 46123
Floyd Memorial Hospital
New Albany, Indiana, United States, 47150
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
Family Medicine East, Chartered/Radiology
Wichita, Kansas, United States, 67207
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Office of Manoj Kohli, M.D.
Lexington, Kentucky, United States, 40517
L-MARC Research Center
Louisville, Kentucky, United States, 40213
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States, 42431
United States, Louisiana
TFD Research, LLC
Shreveport, Louisiana, United States, 71115
United States, Maine
Rheumatology Associates
Portland, Maine, United States, 04102
United States, Maryland
The Center for Rheumatology and Bone Research
Rockville, Maryland, United States, 20850
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Miray Medical Center
Brockton, Massachusetts, United States, 02301
Phase III Clinical Research
Fall River, Massachusetts, United States, 02720
Fall River Clinical Research
Fall River, Massachusetts, United States, 02721
HCI Metromedic Walk-In
New Bedford, Massachusetts, United States, 02740
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481-2106
Fallon Clinic, Inc. (Drug Shipment)
Worcester, Massachusetts, United States, 01605
Fallon Clinic, Inc.
Worcester, Massachusetts, United States, 01605
United States, Michigan
Cadillac Clinical Research, LLC, located at Great Lakes Family Care
Cadillac, Michigan, United States, 49601
United States, Mississippi
Arthritis and Osteoporosis Treatment and Research Center
Flowood, Mississippi, United States, 39232
Planters Clinic
Port Gibson, Mississippi, United States, 39150
North Mississippi Medical Center, Inc.
Tupelo, Mississippi, United States, 38801
United States, Missouri
Mercy Medical Group/Woodlake Research
Clarkson Valley, Missouri, United States, 63011
Dynamic Clinical Research, Inc.
Kansas City, Missouri, United States, 64114
Joan Prouty Moore, MD
Kansas City, Missouri, United States, 64114
Orthopaedic and Occupational Medicine
Kansas City, Missouri, United States, 64114
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States, 64114
United States, Nevada
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, United States, 89106
Office of Michael Mall, M.D.
Las Vegas, Nevada, United States, 89109
Nevada Imaging Centers
Las Vegas, Nevada, United States, 89117
Nevada Imaging Centers
Las Vegas, Nevada, United States, 89118
Office of Danka Michaels, MD
Las Vegas, Nevada, United States, 89128
Office of Stephen H. Miller, MD
Las Vegas, Nevada, United States, 89144
United States, New York
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
NYU Hospital for Joint Diseases
New York, New York, United States, 10003
VirtualScopics, Inc.
Rochester, New York, United States, 14625
Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York
Syracuse, New York, United States, 13210
United States, North Carolina
Kernodle Clinic Inc.
Burlington, North Carolina, United States, 27215
Southeastern Radiology
Greensboro, North Carolina, United States, 27407
PharmQuest
Greensboro, North Carolina, United States, 27408
Research Institute of the Carolinas, PLLC
Mooresville, North Carolina, United States, 28117
PMG Research of Salisbury
Salisbury, North Carolina, United States, 28144
Piedmont Healthcare/Research
Statesville, North Carolina, United States, 28625
Carolina Arthritis Associates, PA
Wilmington, North Carolina, United States, 28401
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Internal Medicine Associates
Fargo, North Dakota, United States, 58103
Lillestol Research, LLC
Fargo, North Dakota, United States, 58103
United States, Ohio
Advantage Diagnostics
Beachwood, Ohio, United States, 44122
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
Columbus Clinical Research, Inc.
Columbus, Ohio, United States, 43213
Optimed Research, LLC
Columbus, Ohio, United States, 43235
Lake Health Lyndhurst Clinic
Lyndhurst, Ohio, United States, 44124
United States, Pennsylvania
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, United States, 18015
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
BioImaging Technologies, Inc.
Newtown, Pennsylvania, United States, 18940
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Rheumatology Associates
Charleston, South Carolina, United States, 29407
Radiant Research, Inc.
Greer, South Carolina, United States, 29651
United States, Tennessee
Parkway Medical Group
Fayetteville, Tennessee, United States, 37334
Holston Medical Group
Kingsport, Tennessee, United States, 37660
D. Matthew Sellers MD PC
Knoxville, Tennessee, United States, 37920
Southwind Medical Specialists
Memphis, Tennessee, United States, 38125
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75231
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Radiant Research San Antonio Northeast
San Antonio, Texas, United States, 78217
South Texas Radiology Imaging Center
San Antonio, Texas, United States, 78217
Oakwell Clinical Research, LLC
San Antonio, Texas, United States, 78218
United States, Utah
Pivotal Research Centers
Midvale, Utah, United States, 84047
United States, Virginia
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States, 23502
National Clinical Research, Incorporated
Richmond, Virginia, United States, 23294
Advanced Pain Management
Virginia Beach, Virginia, United States, 23454
United States, Washington
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States, 98405
United States, Wisconsin
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States, 53142
Argentina
OMI - Organización Médica de Investigación
Buenos Aires, Argentina, C1013AAR
Saint Dennis Medical Group S.A.
Buenos Aires, Argentina, C1034ACO
Investigaciones Reumatológicas y Osteológicas S.R.L.
Buenos Aires, Argentina, C1114AAH
Instituto Médico Especializado (IME)
Buenos Aires, Argentina, C1405BCH
IMAI Research
Buenos Aires, Argentina, C1425AWC
Australia, Tasmania
Menzies Research Institute
Hobart, Tasmania, Australia, 7000
Belgium
Cliniques Universitaires St Luc
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Gasthuisberg / Rheumatology
Leuven, Belgium, 3000
Canada, Alberta
Rheumatology Research Associates Ltd.
Edmonton, Alberta, Canada, T5M 0H4
Canada, Newfoundland and Labrador
Nexus Clinic Research
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
The Arthritis Program Research Group Inc.
Newmarket, Ontario, Canada, L3Y 3R7
Canada, Quebec
Centre de Rhumatologie St-Louis
Sainte-Foy, Quebec, Canada, G1W 4R4
Czech Republic
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice, Czech Republic, 615 00
Fakultni nemocnice u sv. Anny v Brne
Brno, Czech Republic, 656 91
MEDIPONT Plus, s.r.o.
Ceske Budejovice, Czech Republic, 370 01
MEDIPONT, s.r.o.
Ceske Budejovice, Czech Republic, 370 01
ARTMEDI UPD s r.o.
Hostivice, Czech Republic, 253 01
DC Mediscan
Praha 11 - Chodov, Czech Republic, 148 00
MediCentrum Praha, a.s.
Praha 11 - Chodov, Czech Republic, 148 00
Nemocnice Na Frantisku s poliklinikou
Praha 1, Czech Republic, 11000
Revmatologicky ustav
Praha 2, Czech Republic, 128 50
Centrum pro zdravotnicke zabezpeceni sportovni reprezentace
Praha 6, Czech Republic, 162 00
Ustredni vojenska nemocnice Praha
Praha 6, Czech Republic, 162 00
MSI - Muskuloskeletalni institut
Praha 6, Czech Republic, 169 00
Nemocnice Atlas, a.s.
Zlin, Czech Republic, 760 01
PV-Medical s.r.o.
Zlin, Czech Republic, 760 01
Germany
Praxis fuer Orthopaedie, Chirotherapie und Akupunktur
Bad Hersfeld, Germany, 36251
Praxis fuer Orthopaedie
Berlin, Germany, 12247
Klinische Forschung Berlin-Buch
Berlin, Germany, 13125
Praxis Dr. Thomas Jung
Deggingen, Germany, 73326
Klinische Forschung Schwerin
Schwerin, Germany, 19055
Hungary
Orszagos Gerincgyogyaszati Kozpont
Budapest, Hungary, 1126
Synexus Magyarorszag Kft.
Budapest, Hungary, H-1036
Heves Megyei Onkormanyzat Markhot Ferenc Korhaz
Eger, Hungary, 3300
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz, Reumatologia
Gyula, Hungary, 5700
Selye Janos Korhaz, Reumatologiai Szakrendelo
Komarom, Hungary, 2900
MAV Korhaz es Rendelointezet
Szolnok, Hungary, H-5000
Veszprem Megyei Onkormanyzat Csolnoky Ferenc Korhaz-Rendelointezet
Veszprem, Hungary, H-8200
Italy
Azienda Sanitaria Genovese, Ospedale La Colletta, Dipartimento Apparato Locomotore
Arenzano, Italy, 16011
Presidio Ospedaliero Augusto Murri, Reparto di Reumatologia
Jesi (Ancona), Italy, 60035
Ospedale Luigi Sacco, Azienda Ospedaliera Polo Universitario Unita' Operativa di Reumatologia
Milano, Italy, 20157
Peru
Centro Empresarial - Altavista Polo 4
Santiago de Surco, Lima, Peru, Lima 33
Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva
Santiago de Surco, Lima, Peru, Lima 33
Hospital Nacional "Alberto Sabogal Sologuren" - Essalud
Callao, Peru, Callao-02
Clínica San Felipe
Lima, Peru, L-11
Hospital Nacional "Edgardo Rebagliati Martins" - Essalud
Lima, Peru, L-11
Instituto Peruano del Hueso y la Articulación SAC.
Lima, Peru, L-27
Hospital Maria Auxiliadora
Lima, Peru, L-29
Centro Medico Corpac
Lima, Peru, Lima-27
Poland
NSZOZ "MEDICUS II" S.C. Irena Klimczak, Malgorzata Klimczak, Jerzy Klimczak
Cieszyn, Poland, 43-400
"SYNEXUS SCM" Sp. z o.o.
Wroclaw, Poland, 50-088
Katedra i Klinika Ortopedii i Traumatologii Narzadu Ruchu
Wroclaw, Poland, 50-556
Russian Federation
Russian State Medical University, Moscow Faculty, City Clinical Hospital #4
Moscow, Russian Federation, 115093
Institute of Rheumatology
Moscow, Russian Federation, 115522
City Alexandrovskaya Hospital
St. Petersburg, Russian Federation, 193312
L.G. Sokolov Clinical Hospital #122 of Federal Medical-Biology Agency of Russia, Central Polyclinic
St. Petersburg, Russian Federation, 194291
Research Institute of Traumatology and Orthopedy Named After R. R. Vredena
St. Petersburg, Russian Federation, 195427
Slovakia
V. Interna klinika FN a LF UK
Bratislava, Slovakia, 826 06
Ivan Ujvari
Bratislava, Slovakia
Narodny ustav reumatickych chorob
Piestany, Slovakia, 921 12
Spain
Hospital Ntra. Sra. de La Esperanza
Santiago de Compostela, A Coruña, Spain, 15705
Hospital General Universitario de Guadalajara
Guadalajara, Spain, 19002
Hospital Nuestra Señora de Valme
Sevilla, Spain, 41014
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

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 June 28, 2017