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 - ND

PFIZER0 sites1,400 target enrollmentApril 18, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: PFIZER
Enrollment: 1400
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 18, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

PFIZER

Eligibility Criteria

Inclusion Criteria

•1\. Has provided written informed consent and is willing to comply with scheduled visits, treatment plan, radiographs, laboratory tests, and other trial procedures; 2\. Is a female aged \>/\=40 years with a BMI \>/\=30 and \<40 kg/m2; 3\. In the past, has been diagnosed with knee OA and has had knee symptoms in the past year defined as: Pain, aching or stiffness on most days of a month; and/or Used a medication (other than potent opioids) for treatment of knee pain on most days of a month; 4\. Has a current level of pain (outside of acute flare) in at least 1 knee characterized by a WOMAC Pain subscale score of between 6 and 12, inclusive (where the range of subscores is 0\-20\); Note: Pain must be characterized as a subject?s normal day\-to\-day pain while on standard of care medication and not the pain associated with an acute flare. 5\. Has been on the same standard of care medication(s) for OA pain in the knee(s) for at least 3 months and on a stable dosing regimen for at least 4 weeks preceding the first dose of study medication (stable defined as: Doses and frequency of administration remain unchanged); 6\. Is of non\-childbearing potential, if 1 of the 2 categories below is satisfied: Is \>/\=45 years of age and amenorrheic for at least 2 years, or Has proof of a physician documented hysterectomy and/or bilateral oophorectomy; Note: Females not meeting the non\-childbearing rules above or having undergone tubal ligation will be considered of childbearing potential for this study (refer to n.next). 7\. If of childbearing potential, has agreed that when sexually active, to use the protocol designated effective methods of contraception and abide by the time frames described in Section 4\.5\.1\.1; Subjects meeting the following Screen 1 inclusion criteria by radiography as assessed through the modified Lyon\-schuss X\-ray will be semi\-qualified for Screen 2\. Criteria 1\-6 below will be assessed by the independent Central Reader and communicated back to the Central Imaging Core Laboratory, which will then assess the results against the OA history taken at the Screen 1 visit as the final step in determining which subjects will be invited back for Screen 2\. A ?yes? answer to each criterion is needed to continue screening. 1\. A KLG 2 or 3 AND a medial tibiofemoral minimum JSW \>/\=2 mm in the study knee; 2\. A KLG \<4 in the contralateral knee; 3\. An anatomic axis angle between 184 and 174 degrees inclusive in the study knee; 4\. The lateral minimum joint space width (JSW) \> the medial minimum JSW in the study knee; 5\. No radiological findings such as, but not limited to avascular necrosis, fracture, infection, gout, Paget?s disease, osteopetrosis, osteochondritis, or other pathologies in the study knee.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\. Subjects with a history of: a. A diagnosis of any other rheumatic disease (eg, spondyloarthropathies, rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, etc.); b. Current, severe, uncontrolled renal\*, hepatic, hematological, gastrointestinal,metabolic, endocrine, pulmonary, cardiac, neurological disease, or any other condition which would make the subject unsuitable for the study within 6 months preceding the Screen 1 visit; \* Controlled renal dialysis patients will be excluded. c. Uncontrolled diabetes, uncontrolled hyperglycemia, active foot wound infection, or a history of diabetic ulceration; d. Clinically significant infections (acute infection or those requiring hospitalization or requiring parenteral antimicrobial therapy) within 6 months preceding the Screen 1 visit; e. An active malignancy of any type or history of a malignancy (with the exception of subjects with malignancy surgically removed with no evidence of recurrence within the past 5 years, and with the exception of subjects with a history of treated nonmelanoma carcinoma); f. Any known diseases or conditions that may involve the knees including, but not limited to crystalline disease (eg, gout, pseudogout),endocrinopathies (eg, acromegaly), metabolic diseases (eg, ochronosis, hemochromatosis, Wilson?s disease, Gaucher?s disease), septic arthritis, neuropathic disorders, mechanical disorders (eg, hypermobility), avascular necrosis, intra\-articular fracture, microfractures, cartilaginous debridment, chondrocyte transplantation, osteotomy, arthroplasty, mosaicplasty, ACL rupture, partial or total meniscectomy, osteophyte resection, or any other tissue\-related injuries to the knees, Paget?s disease, tumors, (eg, primary osteochondromatosis), or collagen gene mutations; g. Significant trauma to the knees (including arthroscopy or significant injury to ligaments or menisci of the knee within 1 year preceding the Screen 1 visit; h. Alcoholism or drug abuse within 1 year preceding the Screen 1 visit; 2\. Subjects presenting with: a. A verified systolic blood pressure \>150 mm Hg (if untreated for hypertension) or greater than 160 mm Hg (if treated for hypertension) and/or a diastolic bloodpressure greater than 90 mm Hg; b. An ECG finding considered by the Investigator to be clinically significant; c. Any morbidities (eg, coronary heart disease, hypertension, dyspnea, diabetes, obesity, COPD, emphysema, depression, severe OA) that would curtail workrelated or leisure time physical activities (eg, walking, cooking, gardening, standing) such that these morbidities would contribute to increases in sedentary behaviors (eg, becoming chair\- or bed\-ridden, aka, ?couch potato lifestyle?); d. Chronic potent opioid use(propoxyphene, tramadol, codeine use is acceptable); e. Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy); f. Anticipated need for knee or hip surgery in the next 2 years; g. Exacerbation of OA pain (eg, a flare) in either knee requiring a change in stable treatment within 4 weeks of the Screen 1 visit; h. Symptomatic OA of either hip by history or elicited on physical examination that may confound the interpretation of knee pain; i. Clinically significant non\-articular musculoskeletal pain that cannot be distinguished from knee OA and would interfere with the study assessments of efficacy (eg, anserine bursitis, prepatellar bursitis, nerve entrapment sy