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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.
This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:
Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FX006 32mg | Experimental | Single 5 mL intra-articular (IA) injection Extended-release formulation |
|
| TCA IR 40 mg | Active Comparator | Single 1 mL intra-articular (IA) injection Immediate-release formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FX006 32 mg | Drug | Experimental |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Bodick, MD | Flexion Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center | San Antonio | Texas | 78234 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FX006 32 mg | 3 subjects received FX006 32 mg as a single 5 mL IA injection |
| FG001 | TCA IR 40 mg | 3 subjects received TCA IR 40 mg as a single 1 mL IA injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FX006 32 mg | FX006: Single 5 mL IA injection |
| BG001 | TCA IR 40 mg | TCA IR: Single 1 mL IA injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 5-10 Weeks |
|
Adverse Events were collected following IA administration through the final study visit at week 12.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FX006 32 mg | FX006: Single 5 mL IA injection | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
This study was terminated early with only 5% of the planned study population enrolled, efficacy data were not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Kelley, VP of Medical Affairs | Flexion Therapeutics | 781-305-7142 | skelley@flexiontherapeutics.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000631825 | FX006 |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| TCA IR 40 mg |
| Drug |
Comparator |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12 | 12 weeks |
| Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12 | 12 weeks |
| 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 |
| 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 |
| Average Weekly and Total Consumption of Rescue Medication | 12 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 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." | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 12 weeks |
|
|
| Secondary | Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 12 weeks |
|
|
| Secondary | Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 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 | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | Baseline to >30% improvement |
|
|
| Secondary | Average Weekly and Total Consumption of Rescue Medication | Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed. | Posted | 12 weeks |
|
|
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | TCA IR 40 mg | TCA IR: Single 3 mL IA injection | 0 | 3 | 0 | 3 | 2 | 3 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tooth Infection | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Blood triglycerides increased | Infections and infestations | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | Systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |