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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
215
Participants receive ASP7962 100 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Participants receive naproxen 500 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Participants receive matching placebo orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Site BE32003
Leuven, Belgium
Change from Baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The pain subscale contains five questions that ask about pain during the last 48 hours caused by arthritis in the index knee. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Week 4
Change from Baseline to End of Treatment (EOT) in WOMAC Pain Subscale Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point Numerical Rating Scale (NRS) scale ranging from 0 (none) to 10 (extreme). The pain subscale contains five questions that ask about pain during the last 48 hours caused by arthritis in the index knee. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and EOT (up to 4 weeks)
Change from Baseline to EOT in WOMAC Physical Function Subscale Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The physical function subscale contains 17 questions that ask about the difficulty following daily physical activities. A negative change indicates a reduction/improvement from baseline.
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Site BE32002
Merksem, Belgium
Site BE32004
Yvoir, Belgium
Site CZ42006
Hradec Králové, Czechia
Site CZ42003
Kunovice, Czechia
Site CZ42002
Prague, Czechia
Site CZ42005
Prague, Czechia
Site DE49007
Bayern, Germany
Site DE49006
Berlin, Germany
Site DE49004
Deggingen, Germany
...and 24 more locations
Time frame: Baseline and EOT (up to 4 weeks)
Change from Baseline to EOT in WOMAC Stiffness Subscale Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The stiffness subscale contains two questions that ask about stiffness during the last 48 hours caused by the arthritis. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and EOT (up to 4 weeks)
Change from Baseline to EOT in WOMAC Total Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The total score is the sum of scores from pain, physical function and stiffness subscales. Total score ranges from 0 to 30. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and EOT (up to 4 weeks)
Change from Baseline to EOT in WOMAC Walking Pain Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The walking pain score is based on question 1 of the questionnaire on pain when walking on a flat surface. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and EOT (up to 4 weeks)
Change from Baseline to Weeks 1 and 2 in WOMAC Pain Subscale Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The pain subscale contains five questions that ask about pain during the last 48 hours caused by arthritis in the index knee. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Weeks 1 and 2
Change from Baseline to Weeks 1, 2 and 4 in WOMAC Physical Function Subscale Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The physical function subscale contains 17 questions that ask about the difficulty following daily physical activities. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Weeks 1, 2, and 4
Change from Baseline to Weeks 1, 2 and 4 in WOMAC Stiffness Subscale Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The stiffness subscale contains two questions that ask about stiffness during the last 48 hours caused by the arthritis. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Weeks 1, 2, and 4
Change from Baseline to Weeks 1, 2 and 4 in WOMAC Total Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The total score is the sum of scores from pain, physical function and stiffness subscales. Total score ranges from 0 to 30. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Weeks 1, 2, and 4
Change from Baseline to Weeks 1, 2 and 4 in WOMAC Walking Pain Score
WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The walking pain score is based on question 1 of the questionnaire on pain when walking on a flat surface. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Weeks 1, 2, and 4
Change from Baseline to Weeks 1, 2, 3, 4 and EOT in Mean Daily Average Pain Score Assessed by the Numerical Rating Scale
The NRS is an 11-point scale used to capture the participant's average pain in the last 24 hours on a daily basis. This scale is composed of a single question and the score ranges from 0 to 10, where 0 anchors "no pain" and 10 anchors "pain as bad as you can imagine." The mean daily average NRS pain score was derived from the daily index knee pain ratings recorded by participants in an electronic diary (e-diary) on the last 4 days prior to randomization. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Weeks 1, 2, 3, 4 and EOT (up to 4 weeks)
Change from Baseline Patient Global Assessment (PGA) at Weeks 1, 2, 4 and EOT
The PGA is an 11-point NRS scale used to capture the participant's overall impression at the time of the assessment in the index knee. This is a single question and the score ranges from 0 to 10, where 0 anchors "very good" and 10 anchors "very poor." A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Weeks 1, 2, 4 and EOT (up to 4 weeks)
Percentage of Participants who Achieves ≥ 30% Decrease from Baseline to EOT in WOMAC Pain Subscale Score
This is the percentage of participants who has a reduction from baseline to EOT in WOMAC pain subscale score of ≥ 30%. WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The pain subscale contains five questions that ask about pain during the last 48 hours caused by arthritis in the index knee.
Time frame: Baseline and EOT (up to 4 weeks)
Percentage of Participants who Achieves ≥ 50% Decrease from Baseline to EOT in WOMAC Pain Subscale Score
This is the percentage of participants who has a reduction from baseline to EOT in WOMAC pain subscale score of ≥ 50%. WOMAC is a tri-dimensional, self-administered, patient-centered health status questionnaire designed to capture the elements of pain, stiffness and physical function in participants with OA of the knee and/or hip joints. The questionnaire consists of 24 questions, which are divided into three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). Each question is scored using 11-point NRS scale ranging from 0 (none) to 10 (extreme). The pain subscale contains five questions that ask about pain during the last 48 hours caused by arthritis in the index knee.
Time frame: Baseline and EOT (up to 4 weeks)
Number of Participants with Treatment-Emergent Adverse Events
A TEAE is defined as an adverse event (AE) which starts or worsens after the first dose of study drug until 30 days after taking the last dose of study drug. This includes abnormal laboratory tests, vital signs or electrocardiogram data that are defined as AEs if the abnormality induces clinical signs or symptoms, requires active intervention, interruption or discontinuation of study drug or is clinically significant in the investigator's opinion.
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 8 weeks)
Number of Participants with an Affirmative Response in Columbia - Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
C-SSRS is a questionnaire used for suicide assessment, where participants respond to these questions: (1) Wish to be dead; (2) Non-specific active suicidal thoughts; (3) Active suicidal ideation with any methods (not plan) without intent to act; (4) Active suicidal ideation with some intent to act, without specific plan; and (5) Active suicidal ideation with specific plan and intent.
Time frame: From first dose of study drug up to end of study (up to 8 weeks)
Number of Participants with an Affirmative Response in CSSRS: Suicidal Behavior
C-SSRS is a questionnaire used for suicide assessment, where participants respond to these questions: (1) Preparatory acts or behavior; (2) Aborted attempt; (3) Interrupted attempt; (4) Actual attempt; and (5) Completed suicide.
Time frame: From first dose of study drug up to end of study (up to 8 weeks)
Number of Participants with an Affirmative Response in CSSRS: Suicidal Ideation or Behavior
C-SSRS is a questionnaire used for suicide assessment, where participants respond to any one of the ten suicidal ideation and behavior questions.
Time frame: From first dose of study drug up to end of study (up to 8 weeks)
Number of Participants with an Affirmative Response in CSSRS: Self-injurious Behavior without Suicidal Intent
C-SSRS is a questionnaire used for suicide assessment, where participants respond to the question "Has subject engaged in Non-Suicidal Self-Injurious Behavior?"
Time frame: From first dose of study drug up to end of study (up to 8 weeks)