ot applicable
- Conditions
- Treatment of Pain in osteoarthritis of the kneeTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
- Registration Number
- EUCTR2010-022976-29-AT
- Lead Sponsor
- Flexion Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 128
•Written consent to participate in the study
•Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
•Male or female =40 years of age
•Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months according to American College of Rheumatology (ACR) Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or at Screening
•Radiographic evidence of osteoarthritis in the tibiofemoral compartment of the index knee (Kellgren-Lawrence grades II or III) within 6 months prior to Screening or at Screening (PoC)
• Score of 2 or higher for at least one of the five WOMAC A subscale questions fo the index knee at Screening (SAD only)
•Index knee pain on most days (>15) over the last month (PoC only)
•Mean score for the WOMAC A subscale (Likert 3.1) between 2.0 and 3.5 for the index knee at Screening and Baseline (PoC)
•Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee at Screening and Baseline (PoC)
•If bilateral OA exists, the mean score for the WOMAC A subscale for the contralateral knee must be less than the mean score for the WOMAC A subscale for the index knee at Screening and Baseline (PoC only)
•Body mass index (BMI) = 40 kg/m2
•Willingness to abstain from use of topical pain therapies (e.g., NSAIDS, capsaicin, lidocain patches, heat patches), intra-articular corticosteroids and intra- articular viscosupplementation during the study
Willingness to abstain from NSAIDs narcotics and system corticosteroids during the study (PoC)
•Willingness to abstain from the use of the only permitted rescue medication (acetaminophen/paracetamol) for 48 hours prior to the in-clinic and all out patient visits with the exception of Visit 1 (Screening) (PoC)
•No clinically significant results at Screening (clinical significance of values or findings outside of normal ranges will be determined by the Principal Investigator)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128
;
•Written consent to participate in the study
•Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
•Male or female =40 years of age
•Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months according to American College of Rheumatology (ACR) Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or at Screening
•Radiographic evidence of osteoarthritis in the tibiofemoral compartment of the index knee (Kellgren-Lawrence grades II or III) within 6 months prior to Screening or at Screening (PoC)
• Score of 2 or higher for at least one of the five WOMAC A subscale questions fo the index knee at Screening (SAD only)
•Index knee pain on most days (>15) over the last month (PoC only)
•Mean score for the WOMAC A subscale (Likert 3.1) between 2.0 and 3.5 for the index knee at Screening and Baseline (PoC)
•Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee at Screening and Baseline (PoC)
•If bilateral OA exists, the mean score for the WOMAC A subscale for the contralateral knee must be less than the mean score for the WOMAC A subscale for the index knee at Screening and Baseline (PoC only)
•Body mass index (BMI) = 40 kg/m2
•Willingness to abstain from use of topical pain therapies (e.g., NSAIDS, capsaicin, lidocain patches, heat patches), intra-articular corticosteroids and intra- articular viscosupplementation during the study
Willingness to abstain from NSAIDs narcotics and system corticosteroids during the study (PoC)
•Willingness to abstain from the use of the only permitted rescue medication (acetaminophen/paracetamol) for 48 hours prior to the in-clinic and all out patient visits with the exception of Visit 1 (Screening) (PoC)
•No clinically significant results at Screening (clinical significance of values or findings outside of normal ranges will be determined by the Principal Investigator)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128
Disease-related criteria:
•Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee (PoC)
•Clinically apparent tense effusion in index knee
•Ipsilateral hip osteoarthritis (PoC)
•Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with evaluation of the index knee (PoC)
•History of Reiter’s syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
•Presence of surgical hardware or other foreign body in the index joint
•Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
•Clinical signs and symptoms of active knee infection or crystal disease
Previous or concomitant OA treatment-related criteria:
•Intra-articular corticosteroid within 3 months of Screening
•Intra-articular hyaluronic acid within 6 months of Screening
•Other intra-articular therapy within 3 months of Screening
•Systemic corticosteroid within 2 weeks of Screening (PoC)
•Prior arthroscopic or open surgery of the index knee within 12 months of Screening
•Planned/anticipated surgery of the index knee during the study period
Patient-related criteria:
•Clinically significant cardiac disease as judged by the Principal Investigator (e.g., uncontrolled hypertension).
•Screening on Baseline 12-lead ECG demonstrating QTC > 450 msec in male patients and > 470 msec in female patients (Goldberg et al., 2006) or any clinically significant ECG abnormality as judged by the Principal Investigator .
•History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
•Known or clinically suspected infection with human immunodeficiency virus (HIV), hepatitis C or B viruses
•History of latent or active tuberculosis
•History of positive TB test or a positive screening TST defined as 5+ induration
•Lived in or visited a country where TB is endemic in the 8 weeks prior to Screening
•Other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness that, in the judgment of the Principal Investigator, could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study
•Increased predisposition for the development of infections
•Skin breakdown at the knee where the injection would take place
•History of drug or alcohol dependence in the past 3 years
•Women who are pregnant, nursing or likely to become pregnant during the time of the study
•Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using effective contraception (e.g. condom, oral contraceptives, diaphram or cervical cap , intrauterine device, tubal ligation or other surgical procedure)
•Known sensitivity to ethyl chloride (SAD)
•Known sensitivity to acetaminophen / paracetamol
•Use of any investigational drug or device within 30 days of study start
•Use of any investigational biologic within 60 days of study start
;
Disease-related criteria:
•Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee (PoC)
•Clinically apparent tense effusion in index knee
•Ipsilateral hip osteoarthritis (PoC)
•Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with evaluation of the index knee (PoC)
•History of Reiter’s syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
•Presence of surgical hardware or other foreign body in the index joint
•Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
•Clinical signs and symptoms of active knee infection or crystal disease
Previous or concomitant OA treatment-related criteria:
•Intra-articular corticosteroid within 3 months of Screening
•Intra-articular hyaluronic acid within 6 months of Screening
•Other intra-articular therapy within 3 months of Screening
•Systemic corticosteroid within 2 weeks of Screening (PoC)
•Prior arthroscopic or open surgery of the index knee within 12 months of Screening
•Planned/anticipated surgery of the index knee during the study period
Patient-related criteria:
•Clinically significant cardiac disease as judged by the Principal Investigator (e.g., uncontrolled hypertension).
•Screening on Baseline 12-lead ECG demonstrating QTC > 450 msec in male patients and > 470 msec in female patients (Goldberg et al., 2006) or any clinically significant ECG abnormality as judged by the Principal Investigator .
•History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
•Known or clinically suspected infection with human immunodeficiency virus (HIV), hepatitis C or B viruses
•History of latent or active tuberculosis
•History of positive TB test or a positive screening TST defined as 5+ induration
•Lived in or visited a country where TB is endemic in the 8 weeks prior to Screening
•Other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness that, in the judgment of the Principal Investigator, could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study
•Increased predisposition for the development of infections
•Skin breakdown at the knee where the injection would take place
•History of drug or alcohol dependence in the past 3 years
•Women who are pregnant, nursing or likely to become pregnant during the time of the study
•Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using effective contraception (e.g. condom, oral contraceptives, diaphram or cervical cap , intrauterine device, tubal ligation or other surgical procedure)
•Known sensitivity to ethyl chloride (SAD)
•Known sensitivity to acetaminophen / paracetamol
•Use of any investigational drug or device within 30 days of study start
•Use of any investigational biologic within 60 days of study start
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method