A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee
NCT ID: NCT02611466
Last Updated: 2024-10-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
215 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-02-16
Study Completion Date
2017-09-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
NCT01557816
Osteoarthritis, Knee
UNKNOWN
NA
A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)
NCT00772967
Osteoarthritis
COMPLETED
PHASE1
Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
NCT01102660
Osteoarthritis
COMPLETED
PHASE2
Acute Osteoarthritis Experimental Model Study.
NCT01231490
Osteoarthritis
COMPLETED
PHASE2
A Study of GW842166 in Adults With Osteoarthritis Pain
NCT00447486
Osteoarthritis, Knee
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Osteoarthritis of the Knee
Chronic Lower Back Pain
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ASP7962
Participants receive 100 mg of ASP7962 orally twice daily for 4 weeks.
Group Type
EXPERIMENTAL
ASP7962
Intervention Type
DRUG
Participants receive ASP7962 100 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Naproxen
Participants receive 500 mg of naproxen orally twice daily for 4 weeks.
Group Type
ACTIVE_COMPARATOR
Naproxen
Intervention Type
DRUG
Participants receive naproxen 500 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Placebo
Participants receive placebo orally twice daily for a period of 4 weeks.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Participants receive matching placebo orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ASP7962
Participants receive ASP7962 100 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Intervention Type
DRUG
Naproxen
Participants receive naproxen 500 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Intervention Type
DRUG
Placebo
Participants receive matching placebo orally twice daily, in the morning and evening with or without food (approximately 12 hours).
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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:
1. Age \> 50 years
2. Morning stiffness \< 30 minutes
3. Crepitus on active motion
4. Bony tenderness
5. Bony enlargement
6. No palpable warmth of synovium
* 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:
* Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile
* Or, if of childbearing potential: agree not to try to become pregnant during the study and for 28 days after the final study drug administration, and have a negative pregnancy test at screening and at baseline (visit 2 predose), and if heterosexually active, agree to consistently use a barrier method and 1 form of highly effective birth control starting at screening and continuing throughout the study period and for 28 days after the final study drug administration.
* 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).
* Knee pain and at least 3 of the following 6:
1. Age \> 50 years
2. Morning stiffness \< 30 minutes
3. Crepitus on active motion
4. Bony tenderness
5. Bony enlargement
6. No palpable warmth of synovium
* 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:
* Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile
* Or, if of childbearing potential: agree not to try to become pregnant during the study and for 28 days after the final study drug administration, and have a negative pregnancy test at screening and at baseline (visit 2 predose), and if heterosexually active, agree to consistently use a barrier method and 1 form of highly effective birth control starting at screening and continuing throughout the study period and for 28 days after the final study drug administration.
* 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:
* Known hypersensitivity to tramadol (a patient with intolerance or hypersensitivity is allowed, if the patient accepts to limit rescue medication toparacetamol).
* Asthma, rhinitis, nasal polyps, urticarial or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
* Anticipated coronary artery bypass graft surgery during the study.
* Active or history of peptic ulceration.
* Active or history of gastrointestinal bleeding (with the exception of hemorrhoids) or perforation.
* Patient has any contraindication to tramadol including but not limited to
* Known hypersensitivity to tramadol.
* Patient has used a monoamine oxidase inhibitor within 2 weeks prior to screening or during the screening or baseline periods.
* 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:
* Lifetime history of ischemic or hemorrhagic stroke, cardiac arrest, torsade de pointes, clinically significant structural heart disease or a personal or family history of long QT syndrome.
* Within 12 months prior to visit 2: acute coronary syndrome (e.g., myocardial infarction, unstable angina \[ischemic heart disease is allowed\]); transient ischemic attack; coronary or peripheral revascularization procedure; clinically significant cardiac arrhythmias (including atrial fibrillation or flutter), heart block (first degree heart block is allowed provided PR interval is not greater than 240 msec) or other clinically significant cardiovascular disorder.
* Current heart failure (New York Heart Association \[NYHA\] class III and IV).
* 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:
* Patient has (according to the investigator) clinically significant abnormalities in clinical chemistry, hematology or urinalysis at screening. These assessments may be repeated once, after a reasonable time period at the investigator's discretion (but within the screening period).
* Patient has any liver tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin \[TBL\]) \> 1.5 times the upper limit of normal \[ULN\] at screening. These assessments may be repeated once, after a reasonable time period at the investigator's discretion (but within the screening period).
* Patient has an estimated glomerular filtration rate of ≤ 60 mL/min/1.73m2 (Modification of Diet in Renal Disease \[MDRD\] calculation) at screening.
* Patient has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV \[IgM\]), hepatitis C virus antibodies (anti-HCV), or antibodies to human immunodeficiency virus type 1(HIV-1) and/or type 2 (HIV-2) at screening.
Prior Medication / Medical Intervention:
* Patient has received any investigational drug within 28 days (or 5 half-lives of the investigational drug, whichever is longer) before screening or is scheduled to receive an investigational drug other than blinded study treatments during the course of this study.
* Patient has previously received antibodies to NGF within 3 months prior to screening.
* Patient has had any major surgery or orthopedic surgery within 3 months before screening or has plans for surgical intervention during the study.
* Patient who is not a suitable candidate for joint replacement surgery and who is unable to stop chronic NSAID use.
* Patient has received intra-articular corticosteroid or intra-articular local anesthetics within 3 months prior to screening, intra-articular hyaluronic acid within 6 months prior to screening or any of these therapies during the screening or baseline periods.
* Patient has received systemic corticosteroids within the past 30 days before screening or during the screening or baseline periods (topical, nasal and inhaled corticosteroids are permitted.)
* Patient has received any medications or nonmedication therapy with efficacy in reducing pain of OA of the knee, including over-the-counter (OTC) products (with the exception of ice packs, rest, and paracetamol) during the baseline period.
* Patient has started or stopped physiotherapy, acupuncture or transcutaneous electrical nerve stimulation related to treatment of the index knee within 4 weeks prior to screening or during the screening or baseline periods. Stable regimens of these therapies introduced more than 4 weeks prior to screening will be allowed if the regimen is to continue unchanged during the study.
* Patient has used opioids for more than 4 days during the week preceding screening or during the screening period; or has received any opioids during the baseline period.
* Patient has used dipeptidyl peptidase 4 (DPP-4) inhibitors within 12 months prior to visit 2.
* Patient has regularly used any strong systemic inducer of cytochrome P450 (CYP) 3A metabolism (e.g., rifampin, St John's wort) in the 3 months before visit 2.
* Patient has not complied with the requirements for restricted and prohibited medications and nonmedication therapies during the baseline period.
Recreational Drug Use:
* Patient has a positive drug screen for alcohol or recreational drugs (including cannabinoids) or nonprescribed controlled substances at screening (these assessments may be repeated once, after a reasonable time period at the investigator's discretion, but within the screening period) or at baseline.
* Patient has a history of alcohol or drug abuse/dependence/misuse within 1 year prior to screening.
General:
* Patient has any painful condition syndrome (e.g., neuropathy, fibromyalgia) or other concurrent medical or arthritic condition that has the potential to confound the assessment of pain in the index knee, in the investigator's opinion.
* Patient has a Hospital Anxiety and Depression Scale (HADS) score \> 12 on either subscale at screening or baseline (visit 2 predose).
* Patient is involved in an ongoing or settled workers compensation claim, disability or litigation related to the index knee or any pain problem.
* Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation.
* Patient is an employee of the Astellas Group, the Contract Research Organization (CRO) involved or the investigator site executing the study.
* 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:
* Known hypersensitivity to tramadol (a patient with intolerance or hypersensitivity is allowed, if the patient accepts to limit rescue medication toparacetamol).
* Asthma, rhinitis, nasal polyps, urticarial or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
* Anticipated coronary artery bypass graft surgery during the study.
* Active or history of peptic ulceration.
* Active or history of gastrointestinal bleeding (with the exception of hemorrhoids) or perforation.
* Patient has any contraindication to tramadol including but not limited to
* Known hypersensitivity to tramadol.
* Patient has used a monoamine oxidase inhibitor within 2 weeks prior to screening or during the screening or baseline periods.
* 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:
* Lifetime history of ischemic or hemorrhagic stroke, cardiac arrest, torsade de pointes, clinically significant structural heart disease or a personal or family history of long QT syndrome.
* Within 12 months prior to visit 2: acute coronary syndrome (e.g., myocardial infarction, unstable angina \[ischemic heart disease is allowed\]); transient ischemic attack; coronary or peripheral revascularization procedure; clinically significant cardiac arrhythmias (including atrial fibrillation or flutter), heart block (first degree heart block is allowed provided PR interval is not greater than 240 msec) or other clinically significant cardiovascular disorder.
* Current heart failure (New York Heart Association \[NYHA\] class III and IV).
* 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:
* Patient has (according to the investigator) clinically significant abnormalities in clinical chemistry, hematology or urinalysis at screening. These assessments may be repeated once, after a reasonable time period at the investigator's discretion (but within the screening period).
* Patient has any liver tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin \[TBL\]) \> 1.5 times the upper limit of normal \[ULN\] at screening. These assessments may be repeated once, after a reasonable time period at the investigator's discretion (but within the screening period).
* Patient has an estimated glomerular filtration rate of ≤ 60 mL/min/1.73m2 (Modification of Diet in Renal Disease \[MDRD\] calculation) at screening.
* Patient has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV \[IgM\]), hepatitis C virus antibodies (anti-HCV), or antibodies to human immunodeficiency virus type 1(HIV-1) and/or type 2 (HIV-2) at screening.
Prior Medication / Medical Intervention:
* Patient has received any investigational drug within 28 days (or 5 half-lives of the investigational drug, whichever is longer) before screening or is scheduled to receive an investigational drug other than blinded study treatments during the course of this study.
* Patient has previously received antibodies to NGF within 3 months prior to screening.
* Patient has had any major surgery or orthopedic surgery within 3 months before screening or has plans for surgical intervention during the study.
* Patient who is not a suitable candidate for joint replacement surgery and who is unable to stop chronic NSAID use.
* Patient has received intra-articular corticosteroid or intra-articular local anesthetics within 3 months prior to screening, intra-articular hyaluronic acid within 6 months prior to screening or any of these therapies during the screening or baseline periods.
* Patient has received systemic corticosteroids within the past 30 days before screening or during the screening or baseline periods (topical, nasal and inhaled corticosteroids are permitted.)
* Patient has received any medications or nonmedication therapy with efficacy in reducing pain of OA of the knee, including over-the-counter (OTC) products (with the exception of ice packs, rest, and paracetamol) during the baseline period.
* Patient has started or stopped physiotherapy, acupuncture or transcutaneous electrical nerve stimulation related to treatment of the index knee within 4 weeks prior to screening or during the screening or baseline periods. Stable regimens of these therapies introduced more than 4 weeks prior to screening will be allowed if the regimen is to continue unchanged during the study.
* Patient has used opioids for more than 4 days during the week preceding screening or during the screening period; or has received any opioids during the baseline period.
* Patient has used dipeptidyl peptidase 4 (DPP-4) inhibitors within 12 months prior to visit 2.
* Patient has regularly used any strong systemic inducer of cytochrome P450 (CYP) 3A metabolism (e.g., rifampin, St John's wort) in the 3 months before visit 2.
* Patient has not complied with the requirements for restricted and prohibited medications and nonmedication therapies during the baseline period.
Recreational Drug Use:
* Patient has a positive drug screen for alcohol or recreational drugs (including cannabinoids) or nonprescribed controlled substances at screening (these assessments may be repeated once, after a reasonable time period at the investigator's discretion, but within the screening period) or at baseline.
* Patient has a history of alcohol or drug abuse/dependence/misuse within 1 year prior to screening.
General:
* Patient has any painful condition syndrome (e.g., neuropathy, fibromyalgia) or other concurrent medical or arthritic condition that has the potential to confound the assessment of pain in the index knee, in the investigator's opinion.
* Patient has a Hospital Anxiety and Depression Scale (HADS) score \> 12 on either subscale at screening or baseline (visit 2 predose).
* Patient is involved in an ongoing or settled workers compensation claim, disability or litigation related to the index knee or any pain problem.
* Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation.
* Patient is an employee of the Astellas Group, the Contract Research Organization (CRO) involved or the investigator site executing the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Europe B.V.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Officer
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site BE32003
Leuven, , Belgium
Site Status
Site BE32002
Merksem, , Belgium
Site Status
Site BE32004
Yvoir, , Belgium
Site Status
Site CZ42006
Hradec Králové, , Czechia
Site Status
Site CZ42003
Kunovice, , Czechia
Site Status
Site CZ42002
Prague, , Czechia
Site Status
Site CZ42005
Prague, , Czechia
Site Status
Site DE49007
Bayern, , Germany
Site Status
Site DE49006
Berlin, , Germany
Site Status
Site DE49004
Deggingen, , Germany
Site Status
Site DE49003
Leipzig, , Germany
Site Status
Site DE49001
Magdeburg, , Germany
Site Status
Site DE49005
Munich, , Germany
Site Status
Site HU36002
Baja, , Hungary
Site Status
Site HU36008
Balatonfüred, , Hungary
Site Status
Site HU36005
Békéscsaba, , Hungary
Site Status
Site HU36007
Budapest, , Hungary
Site Status
Site HU36006
Debrecen, , Hungary
Site Status
Site HU36001
Esztergom, , Hungary
Site Status
Site HU36003
Komárom, , Hungary
Site Status
Site HU36009
Szeged, , Hungary
Site Status
Site HU36004
Veszprém, , Hungary
Site Status
Site ES34002
A Coruña, , Spain
Site Status
Site ES34001
Barakaldo, , Spain
Site Status
Site ES34008
Barcelona, , Spain
Site Status
Site ES34012
Barcelona, , Spain
Site Status
Site ES34003
Bilbao, , Spain
Site Status
Site ES34005
Madrid, , Spain
Site Status
Site ES34004
Santiago de Compostela, , Spain
Site Status
Site ES34010
Valencia, , Spain
Site Status
Site GB44006
London, , United Kingdom
Site Status
Site GB44011
North Shields, , United Kingdom
Site Status
Site GB44010
Oxfordshire, , United Kingdom
Site Status
Site GB44012
West Midlands, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Belgium
Czechia
Germany
Hungary
Spain
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Watt FE, Blauwet MB, Fakhoury A, Jacobs H, Smulders R, Lane NE. Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis: results from a randomized controlled phase 2a trial. Osteoarthritis Cartilage. 2019 Nov;27(11):1590-1598. doi: 10.1016/j.joca.2019.05.029. Epub 2019 Jul 26.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
https://astellasclinicalstudyresults.com/study.aspx?ID=289
Link to results on the Astellas Clinical Study Results website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-004996-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7962-CL-0022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee
NCT04675034
COMPLETED
PHASE2
Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee
NCT00878501
TERMINATED
PHASE2
Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
NCT00542555
COMPLETED
PHASE3
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
NCT00689273
COMPLETED
PHASE2
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis
NCT01343303
COMPLETED
PHASE1
A Study of MEDI7352 in Painful Osteoarthritis of the Knee
NCT02508155
COMPLETED
PHASE1
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
NCT00504127
COMPLETED
PHASE3
Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
NCT03727022
COMPLETED
PHASE2
A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
NCT00396955
TERMINATED
PHASE2
Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
NCT00372801
COMPLETED
PHASE1
Understanding Pain Mechanisms in Knee Osteoarthritis
NCT05561010
UNKNOWN
NA
An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee
NCT00211549
COMPLETED
PHASE2
A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee
NCT02847702
TERMINATED
PHASE2
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee
NCT02126826
COMPLETED
PHASE1
A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
NCT03161093
COMPLETED
PHASE3
A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee
NCT00265304
COMPLETED
PHASE2
A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)
NCT00269191
COMPLETED
PHASE3
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
NCT04683627
COMPLETED
PHASE3
A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain
NCT02003118
COMPLETED
PHASE2
A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee
NCT06704932
COMPLETED
PHASE1
Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
NCT03245008
COMPLETED
PHASE2/PHASE3
Study Evaluating AGG-523 in Subjects With Osteoarthritis
NCT00427687
COMPLETED
PHASE1
A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain
NCT00418782
TERMINATED
PHASE2
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
NCT00541489
COMPLETED
PHASE3
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
NCT01207115
COMPLETED
PHASE2