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| ID | Type | Description | Link |
|---|---|---|---|
| 0715N0831 | Other Identifier | Shionogi & Co., Ltd | |
| F1J-JE-HMFX | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
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The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine 60 | Experimental | duloxetine 60 milligram (mg) taken orally every day |
|
| Duloxetine 40 | Experimental | Duloxetine 40 mg taken orally every day |
|
| Placebo | Placebo Comparator | placebo comparator taken orally every day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine hydrochloride - 40 mg | Drug | duloxetine 40 mg taken orally every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg) | Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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). | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries | Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY(1-877-285-4559) OR 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT-5 hours,EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aichi | Japan |
Full Analysis Set Population consisted of all randomized patients who had at least one post-baseline measure of the primary efficacy variable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo comparator taken orally every day |
| FG001 | Duloxetine 40 mg | Duloxetine 40 milligrams (mg) taken orally every day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | placebo taken orally every day |
|
| Duloxetine hydrochloride - 60 mg | Drug | duloxetine 60 mg taken orally every day |
|
|
| Baseline, 12 weeks |
| Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg) | Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine). | Baseline, 12 weeks |
| Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries | Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine). | Baseline, Week 12 |
| Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg) | 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). | Week 12 |
| Patient Global Impression of Improvement Scale at Week 12 | 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). | Week 12 |
| Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10. | Baseline, Week 12 |
| Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10. | Baseline, Week 12 |
| Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) | The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10. | Baseline, Week 12 |
| Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 | The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10. | Baseline, Week 12 |
| Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) | 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 ranges from 0 (no depression) to 63 (severe depression). | Baseline, Week 12 |
| Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 | 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 ranges from 0 (no depression) to 63 (severe depression). | Baseline, Week 12 |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aomori | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chiba | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukui | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukuoka | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukushima | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gunma | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hiroshima | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hokkaido | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT -5 hours, ETS), or speak with your personal physician | Hyōgo | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ibaraki | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kagoshima | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyoto | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miyagi | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Niigata | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT -5 hours, ETS), or speak with your personal physician | Okayama | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ōita | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saitama | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shizuoka | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tochigi | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokushima | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toyama | Japan |
| FG002 | Duloxetine 60 mg | Duloxetine 60 milligrams (mg) taken orally every day |
| Full Analysis Set Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo comparator taken orally every day |
| BG001 | Duloxetine 40 mg | Duloxetine 40 milligrams (mg) taken orally every day |
| BG002 | Duloxetine 60 mg | Duloxetine 60 milligrams (mg) taken orally every day |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Duration of Diabetes | Number | participants |
| ||||||||||||||||
| Type of Diabetes | Number | participants |
| ||||||||||||||||
| Beck Depression Inventory-II (BDI-II) | 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 ranges from 0 (no depression) to 63 (severe depression). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/square meters (kg/m^2) |
| ||||||||||||||
| Brief Pain Inventory (BPI) Interference Scores | The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has total scores ranging from 0 to 10. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Brief Pain Inventory (BPI) Severity Scores | A self-reported scale that measures the severity of pain and the interference of pain on function. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Duration of Diabetic Neuropathy | Mean | Standard Deviation | years |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||
| Weekly Means of 24-Hour Average Pain, Worst Pain, and Night Pain Diary Scores | 24-hour average pain severity scores recorded in a diary daily on an 11-point numerical rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point numerical rating scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Total scores for each pain assessment (average, worst, night) range from 0 to 10. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg) | Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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 in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries | Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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 in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg) | Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine). | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries | Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine). | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg) | 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). | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 12 |
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| Secondary | Patient Global Impression of Improvement Scale at Week 12 | 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). | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10. | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10. | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) | The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10. | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 | The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10. | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg) | 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 ranges from 0 (no depression) to 63 (severe depression). | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 | 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 ranges from 0 (no depression) to 63 (severe depression). | Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo comparator taken orally every day | 6 | 167 | 121 | 167 | ||
| EG001 | Duloxetine 40 mg | Duloxetine 40 milligrams (mg) taken orally every day | 3 | 85 | 71 | 85 | ||
| EG002 | Duloxetine 60 mg | Duloxetine 60 milligrams (mg) taken orally every day | 2 | 86 | 73 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Tuberculous pleurisy | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Facial palsy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thalamus haemorrhage | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
The protocol-specified primary analyses for this study were comparisons between combined duloxetine arms (40 mg + 60 mg) and placebo. The study was powered on combined duloxetine arms and statistical comparisons were not performed among single arms.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| 5 - 10 years |
|
| >= 10 years |
|
| Unknown |
|
| Type II |
|
| Mood |
|
| Walking Ability |
|
| Normal Work |
|
| Relation to People |
|
| Sleep |
|
| Enjoyment of Life |
|
| Average of Interference Scores |
|
| Least Pain |
|
| Average Pain |
|
| Pain Right Now |
|
| Worst Pain Score |
|
| Night Pain Score |
|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
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| Participants |
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