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The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to <6, 6 to <7, and ≥7.
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [baseline], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FX006 32mg | Experimental | Single 5 mL intra-articular (IA) injection Extended-release Formulation |
|
| Normal Saline | Placebo Comparator | Single 5 mL intra-articular (IA) injection |
|
| TCA IR 40 mg | Active Comparator | Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FX006 | Drug | Single 5 mL IA injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Baseline and 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Baseline to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Each Week in Weekly Mean of the ADP Scores | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Weeks 1-11 & Weeks 13-24 |
| Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. |
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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85023 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34791634 | Derived | Ross E, Katz NP, Conaghan PG, Kivitz A, Turk DC, Spitzer AI, Jones DG, Lanier RK, Cinar A, Lufkin J, Kelley SD. Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17. | |
| 30968336 |
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Subjects were screened within 21 days of being randomized.
This study took place at 41 centers across the United States, Canada, Australia, New Zealand, Hong Kong, Denmark, Romania, Estonia and Lithuania. Enrollment took approximately 6 months
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| ID | Title | Description |
|---|---|---|
| FG000 | FX006 32mg | 161 subjects received FX006 32 mg as a single 5 mL IA injection |
| FG001 | Placebo | 162 subjects received normal saline as a single 5 mL IA injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Single 5 mL IA injection |
|
|
| TCA IR 40 | Drug | Single 1 mL IA injection |
|
|
| AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR |
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." |
| Baseline to 12 Weeks |
| Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Baseline through 12 Weeks |
| AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Baseline to 24 Weeks |
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| Weeks 4, 8, 12, 16, 20, and 24 |
| Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Weeks 4, 8, 12, 16, 20 and 24 |
| Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Weeks 4, 8, 12, 16, 20 and 24 |
| Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24 | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life. | Weeks 4, 8, 12, and 24 |
| Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24) | 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." | Weeks 1-24 |
| Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24) | Weeks 1-24 |
| Time to Onset of Pain Relief | Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline | Baseline to >30% improvement (measured up to 30 days) |
| Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Weeks 1-24 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Anaheim | California | 92801 | United States |
| Canoga Park | California | 91303 | United States |
| North Hollywood | California | 91606 | United States |
| San Diego | California | 92103 | United States |
| Denver | Colorado | 80209 | United States |
| Atlantis | Florida | 33462 | United States |
| DeLand | Florida | 32720 | United States |
| Hialeah | Florida | 33012 | United States |
| Sarasota | Florida | 34232 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Prairie Village | Kansas | 66206 | United States |
| Albuquerque | New Mexico | 87102 | United States |
| Cary | North Carolina | 27518 | United States |
| PMG Research of Cary | Cary | North Carolina | United States |
| Charlotte | North Carolina | 28209 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| PMG Research of Knoxville | Knoxville | Tennessee | 37912 | United States |
| PMG Research of Knoxville | Knoxville | Tennessee | 37938 | United States |
| Dallas | Texas | 75231 | United States |
| Newport News | Virginia | 23606 | United States |
| Broadmeadow | New South Wales | 02292 | Australia |
| Geelong | New South Wales | 03220 | Australia |
| Merewether | New South Wales | 02291 | Australia |
| St Leonards | New South Wales | 02065 | Australia |
| Sherwood | Queensland | 04075 | Australia |
| Malvern | Victoria | 03145 | Australia |
| Quebec | Ontario | G1W4R4 | Canada |
| Toronto | Ontario | M9V4B4 | Canada |
| Windsor | Ontario | N8W1E6 | Canada |
| Aalborg | Denmark |
| Ballerup Municipality | Denmark |
| Vejle | Denmark |
| Tallinn | Estonia |
| Hong Kong | Hong Kong |
| Vilnius | 10323 | Lithuania |
| Bucharest | 30463 | Romania |
| Derived |
| Langworthy MJ, Conaghan PG, Ruane JJ, Kivitz AJ, Lufkin J, Cinar A, Kelley SD. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019 Jun;36(6):1398-1411. doi: 10.1007/s12325-019-00944-3. Epub 2019 Apr 9. |
| FG002 | TCA IR 40 mg | 161 subjects received TCA IR 40 mg as a single 1 mL IA injection |
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 486 patients were randomized in the study. Two patients, 1 each in the placebo group and 40 mg TCA IR group, were randomized and not treated. These 2 patients were not included in the FAS, Safety, or PP populations.
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| ID | Title | Description |
|---|---|---|
| BG000 | FX006 32mg | FX006: Single 5 mL IA injection |
| BG001 | Placebo | Normal Saline: Single 5 mL IA injection |
| BG002 | TCA IR 40 mg | TCA IR: Single 1 mL IA injection |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 Weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm | Posted | Least Squares Mean | Standard Error | ADP Pain Scores * Week | Baseline to 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Posted | Least Squares Mean | Standard Error | ADP Pain Scores * Week | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline through 12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for TCA IR 40 mg Relative to Placebo was not a pre-specified Secondary Outcome and therefore not reported | Posted | Least Squares Mean | Standard Error | ADP Pain Scores * Week | Baseline to 24 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine." | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 1-11 & Weeks 13-24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 4, 8, 12, 16, 20, and 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 4, 8, 12, 16, 20 and 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 4, 8, 12, 16, 20 and 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24 | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 4, 8, 12, and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24) | 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." | Posted | Count of Participants | Participants | Weeks 1-24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24) | Posted | Count of Participants | Participants | Weeks 1-24 |
|
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| Other Pre-specified | Time to Onset of Pain Relief | Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline | Posted | Median | 95% Confidence Interval | days | Baseline to >30% improvement (measured up to 30 days) |
|
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| Other Pre-specified | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Posted | Least Squares Mean | Standard Error | tablets (1 tablet = 500 mg) | Weeks 1-24 |
|
|
Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks
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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 32mg | FX006: Single 5 mL IA injection | 0 | 161 | 5 | 161 | 51 | 161 |
| EG001 | Placebo | Normal Saline: Single 5 mL IA injection | 0 | 162 | 3 | 162 | 49 | 162 |
| EG002 | TCA IR 40 mg | TCA IR: Single 1 mL IA injection | 0 | 161 | 4 | 161 | 50 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia: | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthralgia: | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Seizure Tonic Clonic | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Unstable Angina | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
Subsequent to completion of clinical studies extensive testing was performed to assess the actual FX006 dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Kelley, VP of Medical Affairs | Flexion Therapeutics | 781-305-7142 | skelley@flexiontherapeutics.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000631825 | FX006 |
| D014221 | Triamcinolone |
| D000077330 | Saline Solution |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
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| Male |
|
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TCA IR: Single 1 mL IA injection |
|
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