| Primary | Percentage of Participants With Depressive Recurrence After Time (t) in Days | Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy. | All randomized patients. Intent to Treat analysis. | Posted | | Number | | percentage of participants | | Every Visit from Week 34 up to Week 86 (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| | | Title | Denominators | Categories |
|---|
| t=7 days (N=145, N=139) | | | | t=14 days (N=143, N=138) | | |
| | 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 |
|---|
| A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05. | Log Rank | The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine. | <0.001 | No adjustments were made for multiple comparisons. The primary efficacy analysis compared the time to recurrence during the maintenance phase between all duloxetine and placebo patients using the log-rank test, stratified by country at α=.05. | | | | | | 95 | | | | | | No |
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| Secondary | Recurrence Count | Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase. | Number of randomized patients with at least one non-missing postbaseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis. | Posted | | Number | | participants | | Every Visit from Week 35 up to Week 86 (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase. | Number of randomized patients with at least one non-missing post-baseline assessment during the double blind maintenance therapy phase. Intent to Treat analysis. | Posted | | Number | | percentage of participants | | Every Visit from Week 34 up to Week 86 (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Loss of Response at Any Time | Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not. | Number of randomized patients with at least one non-missing post-baseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis. | Posted | | Number | | participants | | Every Visit from Week 35 up to Week 86 (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | Number of randomized patients with a baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. | Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases | 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 enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase | 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 randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 86 (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4). | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4). | Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain). | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain). | Number of randomized patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases | The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity. | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase | The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity. | Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10. | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10. | Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning. | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning. | Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. | Number of enrolled patients in Acute Phase and number who entered Continuation Phase who indicated they had visits to specified health care provider. Intent to Treat analysis. Note: "Other Mental Health Care Worker" wasn't included in table (1 patient in Acute). "Other Health Care Worker" wasn't included in table (2 patients in Continuation). | Posted | | Mean | Standard Deviation | visits | | Week 0 through Week10 (Acute) through Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. | Number of randomized patients who indicated they had visits to specified health care provider. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | visits | | Week 34 through Week 86 (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. | Number of enrolled patients in the Acute Phase who work for pay. Number of patients who entered the Continuation Phase who work for pay. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | hours | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. | Number of randomized patients who work for pay. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | hours | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. | Number of enrolled patients in the Acute Phase who work for pay and missed work due to illness. Number of patients who entered the Continuation Phase who work for pay and missed work due to illness. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | hours | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute | | | OG001 | Duloxetine - Continuation Phase | |
| |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. | Number of randomized patients who work for pay and missed work due to illness. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | hours | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. | Number of male enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of male patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. | Number of female enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of female patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. | N=Number of male randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Male patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. | N=Number of female randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Female patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases | | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | kilograms | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase | | Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | kilograms | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases | | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | beats per minute | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase | | Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | beats per minute | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | | Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | mm Hg | | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) | | OG001 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase | | Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Least Squares Mean | Standard Error | mm Hg | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | grams per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Giga per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Units per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | actual count | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Giga per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | grams per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | micromoles per Liter | | Week 0 and Week 10 | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | grams per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | micromoles per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | micromoles per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Tera per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Units per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Actual count | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Giga per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | femtoliters | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Giga per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | grams per Liter | | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Continuation Phase | duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | Units per Liter | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | | Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis. | Posted | | Mean | Standard Deviation | millimoles per Liter | | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks. | | OG001 | Placebo | duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks. |
| |
| Secondary | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | | Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis. | Posted | | Number | | participants | | Every Visit from Week 0 up to Week 10 (Acute) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine - Acute Phase | duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint) |
| | |
| Secondary | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | | Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis. | Posted | | Number | | participants | | Every Visit from Week 10 up to Week 34 (Continuation) | | | | ID | Title | Description |
|---|
| OG000 | Duloxetine 60 mg | duloxetine 60 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) | | OG001 | Duloxetine 90 mg | duloxetine 90 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) | | OG002 | Duloxetine 120 mg | duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint) |
| |