Status and phase
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Study type
Funder types
Identifiers
About
The purpose of the study is to evaluate the analgesic efficacy of ASP7962 relative to placebo.
This study will also evaluate the efficacy of ASP7962 relative to placebo on pain on walking, function and stiffness; the time course of efficacy of ASP7962 relative to placebo; the improvement in overall patient status of ASP7962 relative to placebo as well as the safety and tolerability of ASP7962 relative to placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patient has a primary diagnosis of OA of the index knee with symptoms for at least 6 months prior to screening and patient meets American College of Rheumatology clinical classification criteria for OA of the knee, defined by the following:
Knee pain and at least 3 of the following 6:
Patient has a radiographic image of the index knee (according to the minimum quality criteria for radiographic image as set by the central radiology reader) showing evidence of OA with a Kellgren-Lawrence grade ≥2 at screening (based on central reading).
Patient has moderate to severe index knee pain (pain due to OA of the knee at least 5 days per week for the last 3 months prior to screening, as determined by patient's medical history).
Patient is ambulatory and the index knee must not contain any orthopedic and/or prosthetic device.
WOMAC pain subscale score (with a 48-hour recall period) in the index knee ≥ 4 at baseline (visit 2 predose, mean of all questions on pain subscale).
WOMAC physical function subscale score ≥ 4 at baseline (visit 2 predose, mean of all questions on physical function subscale with a 48-hour recall period).
Patient is willing to discontinue all current pain medications during the baseline and treatment periods (until day 57) (except for allowed rescue medications). Low dose aspirin for cardioprophylaxis is allowed.
Patient is compliant with daily pain recording. Compliance with diary completion will be defined as daily average pain ratings on at least 5 days of the baseline period, of which at least 3 days are in the last 4 days prior to visit 2.
Male patient and their female spouse/partners who are of childbearing potential must be using a barrier method and 1 form of highly effective birth control starting at screening and continuing throughout the study period and for 90 days after the final study drug administration.
Male patient must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
Female patient must either:
Female patient must agree not to breastfeed starting at screening and continuing throughout the study period and for 28 days after the final study drug administration.
Female patient must not donate ova starting at screening and continuing throughout the study period and for 28 days after the final study drug administration.
Patient agrees not to participate in another investigational study from screening through the follow-up period (until day 57).
Exclusion criteria
Medical History / Clinical Status:
Patient has a history of suicide attempt or suicidal behavior. Suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale [C-SSRS]), or who are at significant risk to commit suicide, as judged by the investigator at screening and at the time of randomization.
Patient has current or prior psychosis, major depressive disorder or other clinically significant psychiatric disorder.
Patient has a current or prior clinically significant neurologic disease, including but not limited to peripheral neuropathy, stroke, cognitive impairment and seizure. Childhood febrile seizures are not exclusionary.
Patient has any clinically significant uncontrolled musculoskeletal disorder (with the exception of OA), cardiovascular, gastrointestinal, endocrinologic (diabetes mellitus is allowed if controlled [glycated hemoglobin (HbA1c) ≤ 8.0%] and no peripheral neuropathy), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, dermatologic, renal and/or other major disease.
Patient has an active malignancy or a history of malignancy (except for treated nonmelanoma skin cancer) within the past 5 years.
Patient has a history of inflammatory arthritis, (including rheumatoid arthritis or a history of RPOA, osteonecrosis or avascular necrosis of bone and/or joints), or has other diagnoses that may increase the risk of RPOA (e.g., pre-existing atrophic OA, subchondral insufficiency fracture), or severe knee malalignment or any other joint-related condition that makes the patient unsuitable for study participation (e.g., joint pain that is disproportionately severe, or which has atypical features for OA pain, should trigger further medical evaluation to rule out subchondral insufficiency fracture).
Patient has findings suggestive of RPOA or increased risk for RPOA on screening radiographs of either index or non-index joints (based on central reading).
Patient has a history of shoulder surgery, clinically significant trauma or current symptoms, including pain or impaired range of motion at shoulder joint.
Patient has a coagulopathy, is receiving anticoagulants or has been diagnosed with thrombocytopenia or a functional platelet disorder.
Patient has a history of paracetamol intolerance, or existence of medical condition or use of concomitant medication for which paracetamol is contraindicated.
Patient has any contraindication to naproxen including but not limited to:
Patient has any contraindication to tramadol including but not limited to
Patient has a body mass index (BMI) > 39 kg/m2.
Cardiovascular:
Patient has a clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening or baseline (visit 2 predose).
Patient has any of the following:
Patient has a resting pulse rate < 50 or > 100 beats per minute (bpm); systolic blood pressure (SBP) > 160 mm Hg; diastolic blood pressure (DBP) > 90 mm Hg at screening or baseline (visit 2 predose). These assessments may be repeated once, after a reasonable time period at the investigator's discretion. If the repeat measurement is meeting the above criteria, the patient will be excluded.
Patient has a history of unexplained syncopal events or has symptomatic orthostatic hypotension at screening or baseline (visit 2 predose), defined as postural related symptoms and at least one of the following: standing SBP ≥ 20 mm Hg lower than supine SBP, standing DBP ≥ 10 mm Hg lower than supine DBP.
Clinical Chemistry / Hematology:
Prior Medication / Medical Intervention:
Recreational Drug Use:
General:
Primary purpose
Allocation
Interventional model
Masking
215 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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