Diabetic Neuropathies
Conditions
Brief summary
To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.
Interventions
DRUGDuloxetine
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months. * May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study. * Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
Exclusion criteria
* History of substance abuse or dependence within the past year, excluding nicotine and caffeine. * Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study. * Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study. * Treatment with fluoxetine within 30 days of starting the study. * Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item | Baseline (Week 0), Week 34 | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint | Baseline (Week 8), Week 34 | A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint | Week 34 | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint | Week 34 | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint | Baseline (Week 8), Week 34 | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint | Baseline (Week 8), Week 34 | Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint | Baseline (Week 8), Week 34 | This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe). |
| Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint | Baseline (Week 8), Week 34 | This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe). |
| Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. |
| Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint | Baseline (Week 8), Week 34 | A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. |
| Number of Participants Discontinuing in the Acute Phase | Baseline (Week 0) to Week 8 | — |
| Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item | Baseline (Week 0), Week 34 | A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). |
| Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint | Baseline (Week 0), Week 34 | — |
| Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint | Baseline (Week 0), Week 34 | — |
| Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint | Baseline (Week 0), Week 34 | — |
| Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint | Baseline (Week 0), Week 34 | — |
| Number of Participants Discontinuing in Maintenance / Rescue Phase | Baseline (Week 8) to Week 34 | — |
Countries
Brazil, France, Germany, Italy
Participant flow
Pre-assignment details
Study Period I was a 5-9 day Screening Phase. Study Period II was an 8 week Acute Therapy Phase. Study Period III was a 26 week Maintenance and Rescue Therapy Phase. Study Period IV was a 2 week Taper Phase.
Participants by arm
| Arm | Count |
|---|---|
| Acute Phase All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months | 216 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period II - Acute Therapy Phase | Adverse Event | 20 | 0 | 0 |
| Period II - Acute Therapy Phase | Lack of Efficacy | 1 | 0 | 0 |
| Period II - Acute Therapy Phase | Physician Decision | 1 | 0 | 0 |
| Period II - Acute Therapy Phase | Protocol Violation | 2 | 0 | 0 |
| Period II - Acute Therapy Phase | Withdrawal by Subject | 8 | 0 | 0 |
| Period III - Maintenance / Rescue Phase | Adverse Event | 0 | 14 | 5 |
| Period III - Maintenance / Rescue Phase | Death | 0 | 1 | 0 |
| Period III - Maintenance / Rescue Phase | Lack of Efficacy | 0 | 4 | 24 |
| Period III - Maintenance / Rescue Phase | Lost to Follow-up | 0 | 1 | 1 |
| Period III - Maintenance / Rescue Phase | Protocol Violation | 0 | 2 | 5 |
| Period III - Maintenance / Rescue Phase | Withdrawal by Subject | 0 | 7 | 1 |
Baseline characteristics
| Characteristic | Acute Phase |
|---|---|
| Age Continuous | 63.3 years STANDARD_DEVIATION 9.45 |
| Brief Pain Inventory 24-Hour Average Pain Severity | 5.88 units on a scale STANDARD_DEVIATION 1.45 |
| Duration of Diabetes <=2 years | 78 participants |
| Duration of Diabetes >2 years | 138 participants |
| Duration of Neuropathic Pain <=1 year | 38 participants |
| Duration of Neuropathic Pain >1 year | 178 participants |
| Height at Visit 1 (Week -1) | 166.7 centimeters (cm) STANDARD_DEVIATION 10.39 |
| Race/Ethnicity African | 6 participants |
| Race/Ethnicity Caucasian | 173 participants |
| Race/Ethnicity Hispanic | 4 participants |
| Race/Ethnicity West Asian | 33 participants |
| Region of Enrollment Brazil | 66 participants |
| Region of Enrollment France | 43 participants |
| Region of Enrollment Germany | 66 participants |
| Region of Enrollment Italy | 41 participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 112 Participants |
| Type of Diabetes Mellitus Type 1 | 12 participants |
| Type of Diabetes Mellitus Type 2 | 204 participants |
| Weight at Visit 2 (Week 0) | 84.0 kilograms (kg) STANDARD_DEVIATION 18.36 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 135 / 216 | 40 / 81 |
| serious Total, serious adverse events | 18 / 216 | 2 / 81 |
Outcome results
Primary
Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint
Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Patients entering maintenance phase on duloxetine 60 mg QD. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint | 0.35 units on a scale | Standard Deviation 2.09 |
Comparison: Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.p-value: <0.00197.5% CI: [0.35, 0.79]t-test, 1 sided
Secondary
Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint
Time frame: Baseline (Week 0), Week 34
Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint | 2.4 beats per minute | Standard Deviation 10.78 |
| Maintenance Arm (No Dose Increase) | Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint | 0.4 beats per minute | Standard Deviation 11.46 |
Secondary
Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint
Time frame: Baseline (Week 0), Week 34
Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint | -0.1 mm Hg | Standard Deviation 9.39 |
| Maintenance Arm (No Dose Increase) | Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint | -1.0 mm Hg | Standard Deviation 9.18 |
Secondary
Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint
Time frame: Baseline (Week 0), Week 34
Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint | -4.2 mm Hg | Standard Deviation 14.94 |
| Maintenance Arm (No Dose Increase) | Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint | 0.7 mm Hg | Standard Deviation 15.27 |
Secondary
Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint
Time frame: Baseline (Week 0), Week 34
Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint | -1.3 kilograms (kg) | Standard Deviation 4.17 |
| Maintenance Arm (No Dose Increase) | Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint | 0.2 kilograms (kg) | Standard Deviation 3.16 |
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint | -0.82 units on a scale | Standard Deviation 5.8 |
p-value: 0.145t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint | 0.28 units on a scale | Standard Deviation 2.34 |
p-value: 0.216t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint | 0.35 units on a scale | Standard Deviation 2.09 |
p-value: 0.075t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint | 0.11 units on a scale | Standard Deviation 3.06 |
p-value: 0.711t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint | 0.22 units on a scale | Standard Deviation 2.73 |
p-value: 0.406t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint | 0.39 units on a scale | Standard Deviation 2.63 |
p-value: 0.124t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint | 0.63 units on a scale | Standard Deviation 2.72 |
p-value: 0.016t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint | 0.13 units on a scale | Standard Deviation 2.22 |
p-value: 0.55t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint | -0.10 units on a scale | Standard Deviation 2.83 |
p-value: 0.713t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint | 0.59 units on a scale | Standard Deviation 3.22 |
p-value: 0.058t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint | 0.24 units on a scale | Standard Deviation 1.79 |
p-value: 0.16t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint | 0.48 units on a scale | Standard Deviation 2.28 |
p-value: 0.026t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint | 0.29 units on a scale | Standard Deviation 2.78 |
p-value: 0.269t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint | -0.11 units on a scale | Standard Deviation 1.24 |
p-value: 0.368t-test, 2 sided
Secondary
Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Time frame: Baseline (Week 8), Week 34
Population: Number of responders with a baseline and ate least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint | 0.31 units on a scale | Standard Deviation 7.34 |
p-value: 0.666t-test, 2 sided
Secondary
Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 0), Week 34
Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Arm | Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item | 76 participants |
Secondary
Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: Week 34
Population: Number of responders with at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint | 2.32 units on a scale | Standard Deviation 1.33 |
Secondary
Number of Participants Discontinuing in Maintenance / Rescue Phase
Time frame: Baseline (Week 8) to Week 34
Population: Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maintenance Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 24 | 128 participants |
| Maintenance Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 12 | 171 participants |
| Maintenance Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Completing at Week 34 | 119 participants |
| Maintenance Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 16 | 142 participants |
| Maintenance Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Entering at Week 8 | 184 participants |
| Maintenance Arm (No Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 16 | 92 participants |
| Maintenance Arm (No Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 24 | 84 participants |
| Maintenance Arm (No Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Completing at Week 34 | 77 participants |
| Maintenance Arm (No Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 12 | 96 participants |
| Maintenance Arm (No Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Entering at Week 8 | 103 participants |
| Maintenance Arm (Later Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 16 | 11 participants |
| Maintenance Arm (Later Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Entering at Week 8 | 12 participants |
| Maintenance Arm (Later Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 12 | 12 participants |
| Maintenance Arm (Later Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 24 | 10 participants |
| Maintenance Arm (Later Dose Increase) | Number of Participants Discontinuing in Maintenance / Rescue Phase | Completing at Week 34 | 9 participants |
| Rescue Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 24 | 34 participants |
| Rescue Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 12 | 63 participants |
| Rescue Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Entering at Week 8 | 69 participants |
| Rescue Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Continuing at Week 16 | 39 participants |
| Rescue Arm | Number of Participants Discontinuing in Maintenance / Rescue Phase | Completing at Week 34 | 33 participants |
Secondary
Number of Participants Discontinuing in the Acute Phase
Time frame: Baseline (Week 0) to Week 8
Population: Participants in Acute Phase (through Week 8).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maintenance Arm | Number of Participants Discontinuing in the Acute Phase | Initiating at Week 0 | 216 participants |
| Maintenance Arm | Number of Participants Discontinuing in the Acute Phase | Continuing at Week 1 | 201 participants |
| Maintenance Arm | Number of Participants Discontinuing in the Acute Phase | Continuing at Week 8 | 184 participants |
Secondary
Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint | -0.53 units on a scale | Standard Deviation 6.62 |
p-value: 0.512t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint | -0.59 units on a scale | Standard Deviation 3.04 |
p-value: 0.113t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint | -1.39 units on a scale | Standard Deviation 2.57 |
p-value: <0.001t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint | 0.19 units on a scale | Standard Deviation 3.79 |
p-value: 0.678t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint | -1.01 units on a scale | Standard Deviation 3.53 |
p-value: 0.021t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint | -0.29 units on a scale | Standard Deviation 3.62 |
p-value: 0.505t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint | -0.97 units on a scale | Standard Deviation 3.4 |
p-value: 0.022t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint | -0.12 units on a scale | Standard Deviation 3.08 |
p-value: 0.752t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint | -0.84 units on a scale | Standard Deviation 3.69 |
p-value: 0.066t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint | -1.15 units on a scale | Standard Deviation 3.49 |
p-value: 0.009t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint | -0.93 units on a scale | Standard Deviation 3.07 |
p-value: 0.016t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint | -1.12 units on a scale | Standard Deviation 3.49 |
p-value: 0.011t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint | -1.33 units on a scale | Standard Deviation 2.96 |
p-value: <0.001t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint | -0.46 units on a scale | Standard Deviation 1.23 |
p-value: 0.003t-test, 2 sided
Secondary
Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Time frame: Baseline (Week 8), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint | -1.38 units on a scale | Standard Deviation 7.6 |
p-value: 0.138t-test, 2 sided
Secondary
Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Time frame: Baseline (Week 0), Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Arm | Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item | 21 participants |
Secondary
Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: Week 34
Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Arm | Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint | 3.04 units on a scale | Standard Deviation 1.32 |