Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
Brief summary
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.
Detailed description
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: * 32 mg FX006, * normal saline (placebo), or * 40 mg TCA IR. 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.
Interventions
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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 \>=40 years of age * Has symptoms associated with OA of the index knee for at least 6 months prior to Screening * Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA * Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray * Index knee pain for \> 15 days over the last month * 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
Exclusion criteria
* Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal 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 infection in the index knee * Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening * Unstable joint within 12 months of screening * 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 * Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to 12 Weeks | 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 12 for FX006 Relative to TCA IR | Baseline to 12 Weeks | 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. |
| 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 | Baseline through 12 Weeks | 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 FX006 Relative to Placebo | Baseline to 24 Weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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 | — |
| Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Weeks 1-11 & Weeks 13-24 | 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. |
| Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Weeks 1-24 | — |
| Time to Onset of Pain Relief | Baseline to >30% improvement (measured up to 30 days) | 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 |
| Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | 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. |
| Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | 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. |
| 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 | 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. |
Countries
Australia, Canada, Denmark, Estonia, Hong Kong, Lithuania, Romania, United States
Participant flow
Recruitment details
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
Pre-assignment details
Subjects were screened within 21 days of being randomized.
Participants by arm
| Arm | Count |
|---|---|
| FX006 32mg FX006: Single 5 mL IA injection | 161 |
| Placebo Normal Saline: Single 5 mL IA injection | 162 |
| TCA IR 40 mg TCA IR: Single 1 mL IA injection | 161 |
| Total | 484 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Incarceration | 0 | 0 | 1 |
| Overall Study | Instruction from PCP | 1 | 0 | 0 |
| Overall Study | Job Commitments | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 7 | 4 | 4 |
| Overall Study | Lost to Follow-up | 1 | 3 | 0 |
| Overall Study | Patient Relocated | 2 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 2 | 0 |
| Overall Study | Pre-planned Knee surgery | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 3 |
Baseline characteristics
| Characteristic | FX006 32mg | Placebo | TCA IR 40 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 9.52 | 62.4 years STANDARD_DEVIATION 8.89 | 62.3 years STANDARD_DEVIATION 10.08 | 62.1 years STANDARD_DEVIATION 9.49 |
| Sex: Female, Male Female | 103 Participants | 96 Participants | 97 Participants | 296 Participants |
| Sex: Female, Male Male | 58 Participants | 66 Participants | 64 Participants | 188 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 161 | 0 / 162 | 0 / 161 |
| other Total, other adverse events | 51 / 161 | 49 / 162 | 50 / 161 |
| serious Total, serious adverse events | 5 / 161 | 3 / 162 | 4 / 161 |
Outcome results
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.
Time frame: Baseline and 12 Weeks
Population: Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FX006 32mg | 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 | -3.12 units on a scale | Standard Error 0.203 |
| Placebo | 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 | -2.14 units on a scale | Standard Error 0.202 |
p-value: <0.000195% CI: [-1.47, -0.49]longitudinal mixed repeated measures
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.
Time frame: Baseline to 12 Weeks
Population: Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FX006 32mg | 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 | -247.3 ADP Pain Scores * Week | Standard Error 14.89 |
| Placebo | 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 | -145.3 ADP Pain Scores * Week | Standard Error 14.77 |
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.
Time frame: Baseline to 12 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FX006 32mg | AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR | -247.3 ADP Pain Scores * Week | Standard Error 14.89 |
| Placebo | AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR | -231.9 ADP Pain Scores * Week | Standard Error 14.85 |
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.
Time frame: Baseline to 24 Weeks
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FX006 32mg | AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo | -432.5 ADP Pain Scores * Week | Standard Error 30.14 |
| Placebo | AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo | -297.0 ADP Pain Scores * Week | Standard Error 29.9 |
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.
Time frame: Baseline through 12 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FX006 32mg | 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 | -3.12 units on a scale | Standard Error 0.203 |
| Placebo | 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 | -2.86 units on a scale | Standard Error 0.202 |
Other Pre-specified
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Time frame: Weeks 1-24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 21 | 0.92 tablets (1 tablet = 500 mg) | Standard Error 0.143 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 15 | 0.67 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 7 | 0.60 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week1 | 1.01 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 14 | 0.67 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 9 | 0.66 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 13 | 0.68 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 10 | 0.67 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 20 | 0.69 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 12 | 0.62 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 11 | 0.73 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 2 | 0.69 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 23 | 0.94 tablets (1 tablet = 500 mg) | Standard Error 0.143 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 19 | 0.71 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 3 | 0.69 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 22 | 0.98 tablets (1 tablet = 500 mg) | Standard Error 0.143 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 18 | 0.87 tablets (1 tablet = 500 mg) | Standard Error 0.143 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 4 | 0.58 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 8 | 0.63 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 17 | 0.82 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 5 | 0.60 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 24 | 0.95 tablets (1 tablet = 500 mg) | Standard Error 0.144 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 16 | 0.71 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| FX006 32mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 6 | 0.56 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 4 | 1.28 tablets (1 tablet = 500 mg) | Standard Error 0.139 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 8 | 1.24 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 22 | 1.21 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week1 | 1.31 tablets (1 tablet = 500 mg) | Standard Error 0.139 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 2 | 1.39 tablets (1 tablet = 500 mg) | Standard Error 0.139 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 3 | 1.35 tablets (1 tablet = 500 mg) | Standard Error 0.139 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 5 | 1.21 tablets (1 tablet = 500 mg) | Standard Error 0.139 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 6 | 1.24 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 7 | 1.19 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 9 | 1.11 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 10 | 1.21 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 11 | 1.12 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 12 | 1.13 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 13 | 1.14 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 14 | 1.18 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 15 | 1.25 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 16 | 1.15 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 17 | 1.17 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 18 | 1.15 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 19 | 1.23 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 20 | 1.22 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 21 | 1.23 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 23 | 1.20 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| Placebo | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 24 | 1.18 tablets (1 tablet = 500 mg) | Standard Error 0.142 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 15 | 0.90 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 5 | 0.83 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 22 | 0.98 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 16 | 0.93 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 4 | 0.90 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 8 | 0.85 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 17 | 0.95 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 3 | 1.02 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 21 | 1.02 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 18 | 1.08 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 2 | 1.00 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 24 | 1.04 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 11 | 0.89 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 10 | 1.01 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 19 | 0.98 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 12 | 0.93 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 9 | 0.91 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week1 | 1.10 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 13 | 0.97 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 7 | 0.89 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 23 | 0.97 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 14 | 0.98 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 6 | 0.87 tablets (1 tablet = 500 mg) | Standard Error 0.14 |
| TCA IR 40 mg | Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24) | Week 20 | 0.94 tablets (1 tablet = 500 mg) | Standard Error 0.141 |
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.
Time frame: Weeks 4, 8, 12, and 24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| FX006 32mg | 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 | Week 4 | 23.50 units on a scale | Standard Error 1.896 |
| FX006 32mg | 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 | Week 8 | 23.30 units on a scale | Standard Error 1.907 |
| FX006 32mg | 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 | Week 12 | 21.19 units on a scale | Standard Error 1.907 |
| FX006 32mg | 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 | Week 24 | 11.95 units on a scale | Standard Error 1.923 |
| Placebo | 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 | Week 24 | 10.25 units on a scale | Standard Error 1.878 |
| Placebo | 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 | Week 4 | 8.93 units on a scale | Standard Error 1.832 |
| Placebo | 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 | Week 12 | 12.22 units on a scale | Standard Error 1.869 |
| Placebo | 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 | Week 8 | 10.70 units on a scale | Standard Error 1.856 |
| TCA IR 40 mg | 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 | Week 24 | 11.44 units on a scale | Standard Error 1.906 |
| TCA IR 40 mg | 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 | Week 8 | 18.02 units on a scale | Standard Error 1.891 |
| TCA IR 40 mg | 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 | Week 12 | 15.77 units on a scale | Standard Error 1.895 |
| TCA IR 40 mg | 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 | Week 4 | 15.60 units on a scale | Standard Error 1.882 |
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.
Time frame: Weeks 4, 8, 12, 16, 20, and 24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| FX006 32mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 4 | -1.10 units on a scale | Standard Error 0.068 |
| FX006 32mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 8 | -1.02 units on a scale | Standard Error 0.071 |
| FX006 32mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 12 | -0.88 units on a scale | Standard Error 0.071 |
| FX006 32mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 16 | -0.67 units on a scale | Standard Error 0.072 |
| FX006 32mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 20 | -0.61 units on a scale | Standard Error 0.069 |
| FX006 32mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 24 | -0.63 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 24 | -0.49 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 4 | -0.50 units on a scale | Standard Error 0.067 |
| Placebo | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 16 | -0.54 units on a scale | Standard Error 0.071 |
| Placebo | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 20 | -0.51 units on a scale | Standard Error 0.069 |
| Placebo | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 8 | -0.48 units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 12 | -0.50 units on a scale | Standard Error 0.071 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 8 | -0.81 units on a scale | Standard Error 0.07 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 12 | -0.70 units on a scale | Standard Error 0.07 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 24 | -0.56 units on a scale | Standard Error 0.069 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 16 | -0.64 units on a scale | Standard Error 0.071 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 4 | -0.87 units on a scale | Standard Error 0.067 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24. | Week 20 | -0.60 units on a scale | Standard Error 0.068 |
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.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| FX006 32mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 4 | -1.23 units on a scale | Standard Error 0.079 |
| FX006 32mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 8 | -1.24 units on a scale | Standard Error 0.078 |
| FX006 32mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 12 | -1.03 units on a scale | Standard Error 0.079 |
| FX006 32mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 16 | -0.80 units on a scale | Standard Error 0.08 |
| FX006 32mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 20 | -0.66 units on a scale | Standard Error 0.078 |
| FX006 32mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 24 | -0.67 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 24 | -0.58 units on a scale | Standard Error 0.079 |
| Placebo | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 4 | -0.51 units on a scale | Standard Error 0.077 |
| Placebo | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 16 | -0.64 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 20 | -0.64 units on a scale | Standard Error 0.078 |
| Placebo | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 8 | -0.54 units on a scale | Standard Error 0.077 |
| Placebo | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 12 | -0.59 units on a scale | Standard Error 0.078 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 8 | -0.92 units on a scale | Standard Error 0.077 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 12 | -0.80 units on a scale | Standard Error 0.078 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 24 | -0.57 units on a scale | Standard Error 0.079 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 16 | -0.71 units on a scale | Standard Error 0.079 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 4 | -1.00 units on a scale | Standard Error 0.078 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 20 | -0.58 units on a scale | Standard Error 0.077 |
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.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| FX006 32mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 8 | -1.09 units on a scale | Standard Error 0.068 |
| FX006 32mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 12 | -0.93 units on a scale | Standard Error 0.069 |
| FX006 32mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 24 | -0.59 units on a scale | Standard Error 0.069 |
| FX006 32mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 4 | -1.11 units on a scale | Standard Error 0.066 |
| FX006 32mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 16 | -0.69 units on a scale | Standard Error 0.069 |
| FX006 32mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 20 | -0.65 units on a scale | Standard Error 0.068 |
| Placebo | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 16 | -0.59 units on a scale | Standard Error 0.069 |
| Placebo | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 20 | -0.56 units on a scale | Standard Error 0.068 |
| Placebo | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 24 | -0.51 units on a scale | Standard Error 0.069 |
| Placebo | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 8 | -0.53 units on a scale | Standard Error 0.068 |
| Placebo | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 4 | -0.51 units on a scale | Standard Error 0.065 |
| Placebo | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 12 | -0.56 units on a scale | Standard Error 0.068 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 24 | -0.54 units on a scale | Standard Error 0.068 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 4 | -0.87 units on a scale | Standard Error 0.065 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 8 | -0.80 units on a scale | Standard Error 0.068 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 12 | -0.72 units on a scale | Standard Error 0.068 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 20 | -0.57 units on a scale | Standard Error 0.067 |
| TCA IR 40 mg | Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24 | Week 16 | -0.62 units on a scale | Standard Error 0.069 |
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.
Time frame: Weeks 1-11 & Weeks 13-24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 24 | -1.99 units on a scale | Standard Error 0.205 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 16 | -2.73 units on a scale | Standard Error 0.204 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 9 | -3.45 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 22 | -2.18 units on a scale | Standard Error 0.205 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 15 | -2.84 units on a scale | Standard Error 0.204 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 10 | -3.31 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 21 | -2.27 units on a scale | Standard Error 0.204 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 14 | -2.91 units on a scale | Standard Error 0.203 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 11 | -3.21 units on a scale | Standard Error 0.203 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 4 | -3.23 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 13 | -2.96 units on a scale | Standard Error 0.203 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 2 | -2.95 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 20 | -2.44 units on a scale | Standard Error 0.204 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 5 | -3.34 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 1 | -1.9 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 19 | -2.57 units on a scale | Standard Error 0.204 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 6 | -3.48 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 23 | -2.14 units on a scale | Standard Error 0.205 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 18 | -2.60 units on a scale | Standard Error 0.204 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 7 | -3.48 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 3 | -3.20 units on a scale | Standard Error 0.202 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 17 | -2.66 units on a scale | Standard Error 0.204 |
| FX006 32mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 8 | -3.48 units on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 9 | -2.06 units on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 1 | -1.04 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 2 | -1.61 units on a scale | Standard Error 0.201 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 3 | -1.66 units on a scale | Standard Error 0.201 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 4 | -1.84 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 5 | -1.87 units on a scale | Standard Error 0.201 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 6 | -1.95 units on a scale | Standard Error 0.201 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 7 | -2.01 units on a scale | Standard Error 0.201 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 8 | -1.96 units on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 10 | -2.08 units on a scale | Standard Error 0.201 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 11 | -2.13 units on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 13 | -2.21 units on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 14 | -2.18 units on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 15 | -2.12 units on a scale | Standard Error 0.202 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 16 | -2.22 units on a scale | Standard Error 0.203 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 17 | -2.18 units on a scale | Standard Error 0.203 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 18 | -2.13 units on a scale | Standard Error 0.203 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 19 | -2.19 units on a scale | Standard Error 0.203 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 20 | -2.18 units on a scale | Standard Error 0.203 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 21 | -2.16 units on a scale | Standard Error 0.203 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 22 | -2.20 units on a scale | Standard Error 0.204 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 23 | -2.12 units on a scale | Standard Error 0.204 |
| Placebo | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 24 | -2.16 units on a scale | Standard Error 0.203 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 7 | -3.03 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 1 | -2.13 units on a scale | Standard Error 0.201 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 17 | -2.57 units on a scale | Standard Error 0.203 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 6 | -3.20 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 22 | -2.29 units on a scale | Standard Error 0.203 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 18 | -2.55 units on a scale | Standard Error 0.0203 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 5 | -3.11 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 2 | -2.69 units on a scale | Standard Error 0.201 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 19 | -2.48 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 4 | -3.11 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 24 | -2.18 units on a scale | Standard Error 0.203 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 11 | -3.01 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 20 | -2.46 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 13 | -2.87 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 10 | -3.07 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 3 | -2.93 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 14 | -2.73 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 9 | -3.06 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 23 | -2.30 units on a scale | Standard Error 0.203 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 15 | -2.75 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 8 | -3.04 units on a scale | Standard Error 0.202 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 21 | -2.27 units on a scale | Standard Error 0.203 |
| TCA IR 40 mg | Change From Baseline to Each Week in Weekly Mean of the ADP Scores | Week 16 | -2.67 units on a scale | Standard Error 0.203 |
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.
Time frame: Weeks 1-24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FX006 32mg | 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) | Week 7 | 112 Participants |
| FX006 32mg | 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) | Week 2 | 99 Participants |
| FX006 32mg | 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) | Week 3 | 109 Participants |
| FX006 32mg | 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) | Week 4 | 107 Participants |
| FX006 32mg | 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) | Week 5 | 106 Participants |
| FX006 32mg | 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) | Week 6 | 113 Participants |
| FX006 32mg | 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) | Week 1 | 66 Participants |
| FX006 32mg | 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) | Week 8 | 109 Participants |
| FX006 32mg | 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) | Week 9 | 107 Participants |
| FX006 32mg | 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) | Week 10 | 107 Participants |
| FX006 32mg | 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) | Week 11 | 107 Participants |
| FX006 32mg | 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) | Week 12 | 103 Participants |
| FX006 32mg | 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) | Week 13 | 97 Participants |
| FX006 32mg | 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) | Week 14 | 95 Participants |
| FX006 32mg | 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) | Week 15 | 88 Participants |
| FX006 32mg | 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) | Week 16 | 91 Participants |
| FX006 32mg | 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) | Week 17 | 84 Participants |
| FX006 32mg | 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) | Week 18 | 81 Participants |
| FX006 32mg | 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) | Week 19 | 86 Participants |
| FX006 32mg | 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) | Week 20 | 84 Participants |
| FX006 32mg | 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) | Week 21 | 82 Participants |
| FX006 32mg | 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) | Week 22 | 79 Participants |
| FX006 32mg | 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) | Week 23 | 77 Participants |
| FX006 32mg | 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) | Week 24 | 70 Participants |
| Placebo | 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) | Week 22 | 74 Participants |
| Placebo | 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) | Week 1 | 42 Participants |
| Placebo | 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) | Week 13 | 81 Participants |
| Placebo | 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) | Week 17 | 82 Participants |
| Placebo | 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) | Week 2 | 63 Participants |
| Placebo | 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) | Week 11 | 78 Participants |
| Placebo | 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) | Week 21 | 76 Participants |
| Placebo | 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) | Week 3 | 61 Participants |
| Placebo | 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) | Week 14 | 80 Participants |
| Placebo | 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) | Week 23 | 79 Participants |
| Placebo | 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) | Week 4 | 64 Participants |
| Placebo | 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) | Week 10 | 78 Participants |
| Placebo | 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) | Week 18 | 75 Participants |
| Placebo | 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) | Week 5 | 69 Participants |
| Placebo | 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) | Week 15 | 79 Participants |
| Placebo | 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) | Week 12 | 80 Participants |
| Placebo | 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) | Week 6 | 73 Participants |
| Placebo | 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) | Week 9 | 79 Participants |
| Placebo | 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) | Week 24 | 74 Participants |
| Placebo | 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) | Week 7 | 75 Participants |
| Placebo | 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) | Week 16 | 81 Participants |
| Placebo | 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) | Week 19 | 78 Participants |
| Placebo | 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) | Week 8 | 74 Participants |
| Placebo | 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) | Week 20 | 79 Participants |
| TCA IR 40 mg | 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) | Week 8 | 107 Participants |
| TCA IR 40 mg | 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) | Week 9 | 109 Participants |
| TCA IR 40 mg | 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) | Week 10 | 109 Participants |
| TCA IR 40 mg | 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) | Week 11 | 105 Participants |
| TCA IR 40 mg | 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) | Week 20 | 87 Participants |
| TCA IR 40 mg | 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) | Week 12 | 104 Participants |
| TCA IR 40 mg | 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) | Week 23 | 84 Participants |
| TCA IR 40 mg | 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) | Week 13 | 106 Participants |
| TCA IR 40 mg | 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) | Week 14 | 100 Participants |
| TCA IR 40 mg | 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) | Week 21 | 83 Participants |
| TCA IR 40 mg | 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) | Week 15 | 97 Participants |
| TCA IR 40 mg | 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) | Week 24 | 74 Participants |
| TCA IR 40 mg | 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) | Week 16 | 97 Participants |
| TCA IR 40 mg | 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) | Week 1 | 81 Participants |
| TCA IR 40 mg | 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) | Week 2 | 96 Participants |
| TCA IR 40 mg | 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) | Week 17 | 86 Participants |
| TCA IR 40 mg | 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) | Week 3 | 101 Participants |
| TCA IR 40 mg | 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) | Week 22 | 78 Participants |
| TCA IR 40 mg | 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) | Week 4 | 108 Participants |
| TCA IR 40 mg | 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) | Week 5 | 109 Participants |
| TCA IR 40 mg | 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) | Week 18 | 93 Participants |
| TCA IR 40 mg | 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) | Week 6 | 111 Participants |
| TCA IR 40 mg | 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) | Week 7 | 112 Participants |
| TCA IR 40 mg | 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) | Week 19 | 88 Participants |
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)
Time frame: Weeks 1-24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FX006 32mg | 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) | Week 7 | 97 Participants |
| FX006 32mg | 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) | Week 2 | 73 Participants |
| FX006 32mg | 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) | Week 3 | 81 Participants |
| FX006 32mg | 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) | Week 4 | 86 Participants |
| FX006 32mg | 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) | Week 5 | 85 Participants |
| FX006 32mg | 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) | Week 6 | 92 Participants |
| FX006 32mg | 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) | Week 1 | 39 Participants |
| FX006 32mg | 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) | Week 8 | 97 Participants |
| FX006 32mg | 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) | Week 9 | 91 Participants |
| FX006 32mg | 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) | Week 10 | 87 Participants |
| FX006 32mg | 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) | Week 11 | 83 Participants |
| FX006 32mg | 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) | Week 12 | 80 Participants |
| FX006 32mg | 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) | Week 13 | 79 Participants |
| FX006 32mg | 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) | Week 14 | 76 Participants |
| FX006 32mg | 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) | Week 15 | 73 Participants |
| FX006 32mg | 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) | Week 16 | 71 Participants |
| FX006 32mg | 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) | Week 17 | 69 Participants |
| FX006 32mg | 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) | Week 18 | 66 Participants |
| FX006 32mg | 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) | Week 19 | 64 Participants |
| FX006 32mg | 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) | Week 20 | 60 Participants |
| FX006 32mg | 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) | Week 21 | 56 Participants |
| FX006 32mg | 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) | Week 22 | 56 Participants |
| FX006 32mg | 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) | Week 23 | 51 Participants |
| FX006 32mg | 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) | Week 24 | 47 Participants |
| Placebo | 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) | Week 22 | 52 Participants |
| Placebo | 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) | Week 1 | 21 Participants |
| Placebo | 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) | Week 13 | 57 Participants |
| Placebo | 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) | Week 17 | 59 Participants |
| Placebo | 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) | Week 2 | 37 Participants |
| Placebo | 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) | Week 11 | 60 Participants |
| Placebo | 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) | Week 21 | 54 Participants |
| Placebo | 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) | Week 3 | 40 Participants |
| Placebo | 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) | Week 14 | 54 Participants |
| Placebo | 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) | Week 23 | 54 Participants |
| Placebo | 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) | Week 4 | 47 Participants |
| Placebo | 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) | Week 10 | 57 Participants |
| Placebo | 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) | Week 18 | 52 Participants |
| Placebo | 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) | Week 5 | 51 Participants |
| Placebo | 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) | Week 15 | 55 Participants |
| Placebo | 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) | Week 12 | 56 Participants |
| Placebo | 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) | Week 6 | 51 Participants |
| Placebo | 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) | Week 9 | 55 Participants |
| Placebo | 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) | Week 24 | 49 Participants |
| Placebo | 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) | Week 7 | 49 Participants |
| Placebo | 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) | Week 16 | 59 Participants |
| Placebo | 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) | Week 19 | 54 Participants |
| Placebo | 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) | Week 8 | 53 Participants |
| Placebo | 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) | Week 20 | 54 Participants |
| TCA IR 40 mg | 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) | Week 8 | 82 Participants |
| TCA IR 40 mg | 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) | Week 9 | 83 Participants |
| TCA IR 40 mg | 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) | Week 10 | 84 Participants |
| TCA IR 40 mg | 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) | Week 11 | 80 Participants |
| TCA IR 40 mg | 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) | Week 20 | 62 Participants |
| TCA IR 40 mg | 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) | Week 12 | 75 Participants |
| TCA IR 40 mg | 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) | Week 23 | 63 Participants |
| TCA IR 40 mg | 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) | Week 13 | 77 Participants |
| TCA IR 40 mg | 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) | Week 14 | 72 Participants |
| TCA IR 40 mg | 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) | Week 21 | 61 Participants |
| TCA IR 40 mg | 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) | Week 15 | 70 Participants |
| TCA IR 40 mg | 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) | Week 24 | 56 Participants |
| TCA IR 40 mg | 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) | Week 16 | 70 Participants |
| TCA IR 40 mg | 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) | Week 1 | 57 Participants |
| TCA IR 40 mg | 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) | Week 2 | 67 Participants |
| TCA IR 40 mg | 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) | Week 17 | 67 Participants |
| TCA IR 40 mg | 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) | Week 3 | 77 Participants |
| TCA IR 40 mg | 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) | Week 22 | 57 Participants |
| TCA IR 40 mg | 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) | Week 4 | 80 Participants |
| TCA IR 40 mg | 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) | Week 5 | 80 Participants |
| TCA IR 40 mg | 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) | Week 18 | 66 Participants |
| TCA IR 40 mg | 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) | Week 6 | 84 Participants |
| TCA IR 40 mg | 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) | Week 7 | 85 Participants |
| TCA IR 40 mg | 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) | Week 19 | 67 Participants |
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
Time frame: Baseline to >30% improvement (measured up to 30 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FX006 32mg | Time to Onset of Pain Relief | 4 days |
| Placebo | Time to Onset of Pain Relief | 11 days |
| TCA IR 40 mg | Time to Onset of Pain Relief | 3 days |