Post-traumatic Osteoarthritis of the Knee Clinical Trial
Official title:
A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
| Verified date | January 2024 |
| Source | Pacira Pharmaceuticals, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 50 Years |
| Eligibility | Inclusion Criteria: - Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions - Male or female =20 and =50 years of age - Diagnosis of post-traumatic OA of the knee - Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening - Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) - Body mass index (BMI) = 40 kg/m2 - Willingness to abstain from use of restricted medications and therapies during the study Exclusion Criteria: - Prior osteotomy of the index knee - Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain) - Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease - History of, or clinical signs and symptoms of active infection of the index knee - Crystal disease of the index knee within one month of Screening - Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery - IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening - IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening - Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening - Any other IA investigational drug/biologic within 6 months of Screening - Prior use of FX006 - Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period - Type 1 or Type 2 diabetes requiring insulin - Women of child-bearing potential not using effective contraception or who are pregnant or nursing |
| Country | Name | City | State |
|---|---|---|---|
| United States | San Antonio Military Medical Center | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pacira Pharmaceuticals, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10 | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." | 5-10 Weeks | |
| Secondary | Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12 | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." | 12 Weeks | |
| Secondary | Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week | 12 Weeks | ||
| Secondary | Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week | 12 Weeks | ||
| Secondary | Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week | 12 Weeks | ||
| Secondary | WOMAC A (Pain Subscale) | change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12 | 12 weeks | |
| Secondary | WOMAC A1 (Pain on Walking Question) | change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12 | 12 weeks | |
| Secondary | WOMAC B (Stiffness) | change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12 | 12 weeks | |
| Secondary | WOMAC C (Function) | change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12 | 12 weeks | |
| Secondary | WOMAC (Total): | change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12 | 12 weeks | |
| Secondary | Knee Injury and Osteoarthritis Score (KOOS) | change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12 | 12 weeks | |
| Secondary | Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12 | 12 weeks | ||
| Secondary | Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12 | 12 weeks | ||
| Secondary | Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12 | 12 weeks | ||
| Secondary | Time to Onset of Pain Relief | Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline | Baseline to >30% improvement | |
| Secondary | Average Weekly and Total Consumption of Rescue Medication | 12 weeks |