Phase 2 N=1,457 Randomized Triple-blind Treatment

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

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT00565812 ↗

Enrolled (actual)

1,457

Serious AEs

10.5%

Results posted

Dec 2016

Primary outcome: Primary: Rate of Progression of Joint Space Narrowing — -0.101; -0.125; -0.109 mm/year — p=0.508770

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SD-6010 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Progression of Joint Space Narrowing	-0.101; -0.125; -0.109	0.508770
PRIMARY Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	-0.061; -0.069; -0.075	0.312
PRIMARY Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	-0.133; -0.162; -0.136	0.881
SECONDARY Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	39.07; 37.29; 38.45; -5.35; -5.08; -5.50	0.639
SECONDARY Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	7.96; 7.44; 7.59; -1.32; -1.23; -1.25	0.683
SECONDARY Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	3.48; 3.33; 3.44; -0.52; -0.51; -0.51	0.904
SECONDARY Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	27.63; 26.49; 27.39; -3.50; -3.24; -3.72	0.586
SECONDARY Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	40.19; 37.59; 39.37; -7.21; -7.02; -9.12	0.086
SECONDARY Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	2.684; 2.610; 2.634; -0.232; -0.230; -0.202	0.984
SECONDARY Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	2.785; 2.834; 2.831; -0.379; -0.422; -0.415	0.849
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	38.03; 35.13; 38.00; -5.78; -5.71; -7.45	0.220
SECONDARY Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	39.35; 36.55; 38.79; -7.00; -6.68; -7.08	0.738
SECONDARY Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	35.25; 33.01; 35.21; -6.61; -6.41; -6.55	0.911
SECONDARY Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	42.76; 39.44; 41.73; -7.32; -6.93; -7.48	0.613
SECONDARY Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	22.19; 21.49; 21.80; -2.20; -2.24; -2.99	0.069
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	42.75; 41.82; 42.60; -3.50; -4.31; -5.23	0.039 sig
SECONDARY Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	35.67; 36.84; 36.32; 2.59; 2.41; 2.55	0.938
SECONDARY Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	39.99; 40.37; 40.14; 2.06; 2.35; 2.22	0.900
SECONDARY Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	38.81; 39.77; 38.90; 4.07; 3.72; 4.06	0.587
SECONDARY Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	44.77; 46.49; 45.19; 1.33; 1.10; 1.20	0.632
SECONDARY Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	47.57; 49.00; 48.08; 1.52; 0.48; 1.04	0.214
SECONDARY Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	45.15; 46.23; 45.64; 1.11; -0.28; -0.15	0.030 sig
SECONDARY Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	43.73; 43.27; 43.37; 0.05; -0.18; -0.25	0.133
SECONDARY Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	47.01; 47.70; 47.26; 0.95; 0.19; -0.31	0.058
SECONDARY Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	37.38; 38.69; 37.84; 3.26; 3.31; 3.58	0.701
SECONDARY Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	49.65; 49.97; 49.65; -0.13; -1.17; -1.27	0.023 sig
SECONDARY Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	132; 135; 163; 348; 345; 322	—
SECONDARY Number of Participants With EuroQoL-5D Self-Care Domain Score	383; 387; 386; 92; 93; 97	—
SECONDARY Number of Participants With EuroQoL-5D Usual Activity Domain Score	186; 185; 190; 285; 291; 289	—
SECONDARY Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	42; 48; 38; 383; 391; 403	—
SECONDARY Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	297; 306; 303; 166; 164; 168	—
SECONDARY EuroQoL-5D Visual Analog Scale Score	66.75; 68.59; 67.86; 72.34; 72.55; 70.58	—
SECONDARY Number of Participants With Increase in Total Analgesic Medication Use	21; 29; 24; 24; 34; 30	0.875
SECONDARY Number of Participants With Decrease in Total Analgesic Medication Use	29; 38; 43; 29; 38; 47	0.168
SECONDARY Patient Global Impression of Change Score	2.97; 3.02; 3.00	0.709
SECONDARY Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	222; 226; 219	0.810
SECONDARY Number of Participants With Joint Space Narrowing Progression	136; 153; 165	0.047 sig
SECONDARY Number of Participants Applicable for Virtual Joint Replacement	28; 34; 28	0.881

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00565812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.