| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | t-test, 1 sided | | <0.001 | | Mean Difference (Net) | 0.35 | | | | 97.5 | 0.35 | 0.79 | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale. |
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| 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). | 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. | Posted | | Number | | participants | | Baseline (Week 0), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Number | | participants | | Baseline (Week 0), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 34 | | | | ID | Title | Description |
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| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
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| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Maintenance Arm | Duloxetine: 60 milligrams once daily |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Week 8), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Rescue Arm | Duloxetine: 120 milligrams once daily |
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| Secondary | Number of Participants Discontinuing in the Acute Phase | | Participants in Acute Phase (through Week 8). | Posted | | Number | | participants | | Baseline (Week 0) to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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 |
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| Secondary | Number of Participants Discontinuing in Maintenance / Rescue Phase | | Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34) | Posted | | Number | | participants | | Baseline (Week 8) to Week 34 | | | | ID | Title | Description |
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| OG000 | All Maintenance / Rescue Participants | Total of the Maintenance (No Dose Increase), Maintenance (Later Dose Increase) and Rescue arms. Depending on the group the patient was in, they either received duloxetine 60 mg once daily; 60 mg once daily and then increased to 120 mg once daily; or 120 mg once daily. | | OG001 | Maintenance Arm (No Dose Increase) | duloxetine 60 mg once daily | | OG002 | Maintenance Arm (Later Dose Increase) | duloxetine 60 mg once daily and then increasing to 120 mg once daily | | OG003 | Rescue Arm | duloxetine 120 mg once daily |
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| Secondary | Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint | | All patients who received either 60 mg or 120 mg duloxetine once daily. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline (Week 0), Week 34 | | | | ID | Title | Description |
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| OG000 | Duloxetine 60 mg | Duloxetine: 60 milligrams once daily | | OG001 | Duloxetine 120 mg | Duloxetine: 120 milligrams once daily |
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| Secondary | Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint | | All patients who received either 60 mg or 120 mg duloxetine once daily. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (Week 0), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine 60 mg | Duloxetine: 60 milligrams once daily | | OG001 | Duloxetine 120 mg | Duloxetine: 120 milligrams once daily |
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| Secondary | Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint | | All patients who received either 60 mg or 120 mg duloxetine once daily. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline (Week 0), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine 60 mg | Duloxetine: 60 milligrams once daily | | OG001 | Duloxetine 120 mg | Duloxetine: 120 milligrams once daily |
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| Secondary | Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint | | All patients who received either 60 mg or 120 mg duloxetine once daily. | Posted | | Mean | Standard Deviation | kilograms (kg) | | Baseline (Week 0), Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine 60 mg | Duloxetine: 60 milligrams once daily | | OG001 | Duloxetine 120 mg | Duloxetine: 120 milligrams once daily |
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