Back Pain Lower Back Chronic
Conditions
Keywords
Chronic Low Back Pain, CLBP
Brief summary
The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).
Interventions
DRUGDuloxetine
Administered orally
Sponsors
Shionogi
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
(Consecutive Participants): * Participants who have completed the 15-week administration in the phase 3 clinical study of Duloxetine hydrochloride in participants with CLBP, study HMGY (NCT01855919) * Female participants having child-bearing potential must test negative (-) on a pregnancy test (New Participants): * Participants with CLBP present for the preceding 6 months or longer * Participants used nonsteroidal anti-inflammatory drugs for CLBP for less than 14 days on average per month in the past 3 months and less than 14 days in one month prior to study * Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score at participation of study * Female participants having child-bearing potential must test negative (-) on a pregnancy test
Exclusion criteria
(Consecutive Participants): * Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study * Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL) * Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis * Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis * Participants having primary painful condition due to other than CLBP * Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension * Participants treating with a monoamine oxidase inhibitor (MAOI) within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug * Participants answering yes to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section) * Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period * Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug * Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator (New Participants): * Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study * Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 IU/L or total bilirubin higher than 1.6 mg/dL * Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis * Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis * Participants having primary painful condition due to other than CLBP * Participants having a history of low back surgery * Participants having any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder * Participants having major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview * Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension * Participants treating with a MAOI within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug * Participants answering yes to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section) * Participants have known hypersensitivity to multiple medications * Participants are non-ambulatory or require the use of crutches or a walker * Participants having a history of substance abuse or dependence within the past year, excluding nicotine and caffeine * Participants having a positive urine drug screen for any substances of abuse * Participants have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication * Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine * Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period * Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug * Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's | Week 53 | A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI-Improvement) to Week 50 | Week 50 | PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). |
| Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50 | Baseline, Week 50 | CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50 | Baseline, Week 50 | RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability). |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Baseline, Week 50 | SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. |
| Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Baseline, Week 50 | A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. |
| Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50 | Baseline, Week 50 | BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. |
| Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Baseline, Week 53 | C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. |
| Number of Participants With Fall Events From Fall Questionnaire | Week 53 | Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) \* 100. |
| Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50 | Baseline, Week 50 | The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naïve New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52. | 67 |
| Rollover (Pre-Placebo) Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52. | 42 |
| Rollover (Pre-Duloxetine 60 mg) Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52. | 41 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period | Adverse Event | 10 | 4 | 2 |
| Treatment Period | Lack of Efficacy | 0 | 0 | 2 |
| Treatment Period | Physician Decision | 0 | 0 | 2 |
| Treatment Period | Withdrawal by Subject | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Naïve | Rollover (Pre-Placebo) | Rollover (Pre-Duloxetine 60 mg) | Total |
|---|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 13.9 | 57.6 years STANDARD_DEVIATION 12 | 58.8 years STANDARD_DEVIATION 11.1 | 56.4 years STANDARD_DEVIATION 12.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 67 Participants | 42 Participants | 41 Participants | 150 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 67 participants | 42 participants | 41 participants | 150 participants |
| Sex: Female, Male Female | 36 Participants | 22 Participants | 22 Participants | 80 Participants |
| Sex: Female, Male Male | 31 Participants | 20 Participants | 19 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 129 / 151 |
| serious Total, serious adverse events | 8 / 151 |
Outcome results
Primary
Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's
A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Time frame: Week 53
Population: All the enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve | Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's | Drug Related AEs | 42 participants |
| Naïve | Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's | Serious AEs | 4 participants |
| Rollover (Pre-Placebo) | Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's | Serious AEs | 3 participants |
| Rollover (Pre-Placebo) | Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's | Drug Related AEs | 16 participants |
| Rollover (Pre-Duloxetine 60 mg) | Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's | Drug Related AEs | 18 participants |
| Rollover (Pre-Duloxetine 60 mg) | Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's | Serious AEs | 1 participants |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Time frame: Baseline, Week 50
Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Physical Functioning | 10.60 units on a scale | Standard Deviation 15.21 |
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Role (Physical) | 16.88 units on a scale | Standard Deviation 20.73 |
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Bodily Pain | 17.64 units on a scale | Standard Deviation 16.32 |
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | General Health | 8.42 units on a scale | Standard Deviation 13.81 |
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Vitality | 10.07 units on a scale | Standard Deviation 16.64 |
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Social Functioning | 6.90 units on a scale | Standard Deviation 21.24 |
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Role (Emotional) | 11.57 units on a scale | Standard Deviation 20.05 |
| Naïve | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Mental Health | 5.97 units on a scale | Standard Deviation 15.31 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Bodily Pain | 20.26 units on a scale | Standard Deviation 22.09 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Role (Emotional) | 11.51 units on a scale | Standard Deviation 23.2 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | General Health | 8.90 units on a scale | Standard Deviation 14.54 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Vitality | 13.24 units on a scale | Standard Deviation 23.15 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Social Functioning | 8.63 units on a scale | Standard Deviation 19.22 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Physical Functioning | 9.52 units on a scale | Standard Deviation 21.91 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Role (Physical) | 11.31 units on a scale | Standard Deviation 24.24 |
| Rollover (Pre-Placebo) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Mental Health | 8.81 units on a scale | Standard Deviation 14.89 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Bodily Pain | 12.62 units on a scale | Standard Deviation 16.58 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Role (Physical) | 7.01 units on a scale | Standard Deviation 21.66 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Physical Functioning | 10.12 units on a scale | Standard Deviation 17.66 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | General Health | 5.51 units on a scale | Standard Deviation 18.57 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Role (Emotional) | 4.47 units on a scale | Standard Deviation 16.99 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Social Functioning | 3.35 units on a scale | Standard Deviation 20.16 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Vitality | 6.10 units on a scale | Standard Deviation 18.93 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50 | Mental Health | 4.63 units on a scale | Standard Deviation 14.12 |
Secondary
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50
BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.
Time frame: Baseline, Week 50
Population: FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naïve | Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50 | -1.81 units on a scale | Standard Deviation 5.32 |
| Rollover (Pre-Placebo) | Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50 | -1.83 units on a scale | Standard Deviation 5 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50 | -0.56 units on a scale | Standard Deviation 3.75 |
Secondary
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Time frame: Baseline, Week 50
Population: (FAS): All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Average Pain | -3.30 units on a scale | Standard Deviation 1.45 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Worst Pain | -4.16 units on a scale | Standard Deviation 1.91 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Least Pain | -1.82 units on a scale | Standard Deviation 1.54 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Pain Right Now | -2.70 units on a scale | Standard Deviation 1.87 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | General Activity | -3.22 units on a scale | Standard Deviation 2.3 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Mood | -2.52 units on a scale | Standard Deviation 2.55 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Walking Ability | -2.09 units on a scale | Standard Deviation 2.16 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Normal Work | -3.22 units on a scale | Standard Deviation 2.49 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Relationship with People | -1.42 units on a scale | Standard Deviation 2.15 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Sleep | -1.73 units on a scale | Standard Deviation 2.12 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Enjoyment of Life | -2.07 units on a scale | Standard Deviation 2.27 |
| Naïve | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Average of 7 Interference Items | -2.33 units on a scale | Standard Deviation 1.81 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Average of 7 Interference Items | -2.72 units on a scale | Standard Deviation 2.05 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Average Pain | -3.79 units on a scale | Standard Deviation 1.66 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Walking Ability | -2.74 units on a scale | Standard Deviation 2.26 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Relationship with People | -1.79 units on a scale | Standard Deviation 2.37 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Worst Pain | -4.71 units on a scale | Standard Deviation 2.21 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Mood | -3.12 units on a scale | Standard Deviation 2.37 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Enjoyment of Life | -2.50 units on a scale | Standard Deviation 2.55 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Least Pain | -2.52 units on a scale | Standard Deviation 1.77 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Normal Work | -3.21 units on a scale | Standard Deviation 2.23 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | General Activity | -3.26 units on a scale | Standard Deviation 2.51 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Pain Right Now | -3.93 units on a scale | Standard Deviation 1.74 |
| Rollover (Pre-Placebo) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Sleep | -2.40 units on a scale | Standard Deviation 2.56 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Pain Right Now | -2.68 units on a scale | Standard Deviation 1.9 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | General Activity | -2.24 units on a scale | Standard Deviation 2.75 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Sleep | -1.34 units on a scale | Standard Deviation 2.22 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Mood | -2.07 units on a scale | Standard Deviation 2.49 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Walking Ability | -1.71 units on a scale | Standard Deviation 3.11 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Normal Work | -2.05 units on a scale | Standard Deviation 2.78 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Enjoyment of Life | -1.83 units on a scale | Standard Deviation 2.4 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Average Pain | -2.88 units on a scale | Standard Deviation 1.81 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Worst Pain | -3.24 units on a scale | Standard Deviation 1.88 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Relationship with People | -0.83 units on a scale | Standard Deviation 1.82 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Least Pain | -2.12 units on a scale | Standard Deviation 1.71 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50 | Average of 7 Interference Items | -1.72 units on a scale | Standard Deviation 2.21 |
Secondary
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Time frame: Baseline, Week 50
Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naïve | Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50 | 2.09 units on a scale | Standard Deviation 0.81 |
| Rollover (Pre-Placebo) | Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50 | 2.00 units on a scale | Standard Deviation 0.73 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50 | 2.73 units on a scale | Standard Deviation 0.98 |
Secondary
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Time frame: Baseline, Week 53
Population: All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.LOCF was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Naïve | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Nonspecific suicidal thoughts (n=67,42,41) | 0 participants |
| Naïve | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Suicidal Ideation- wish to be dead (n=65,39,40) | 0 participants |
| Naïve | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Suicidal Behavior (n=67,42,41) | 0 participants |
| Rollover (Pre-Placebo) | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Nonspecific suicidal thoughts (n=67,42,41) | 0 participants |
| Rollover (Pre-Placebo) | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Suicidal Ideation- wish to be dead (n=65,39,40) | 0 participants |
| Rollover (Pre-Placebo) | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Suicidal Behavior (n=67,42,41) | 0 participants |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Suicidal Ideation- wish to be dead (n=65,39,40) | 0 participants |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Suicidal Behavior (n=67,42,41) | 0 participants |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52 | Nonspecific suicidal thoughts (n=67,42,41) | 0 participants |
Secondary
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.
Time frame: Baseline, Week 50
Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naïve | Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50 | 0.16 units on a scale | Standard Deviation 0.16 |
| Rollover (Pre-Placebo) | Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50 | 0.15 units on a scale | Standard Deviation 0.15 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50 | 0.11 units on a scale | Standard Deviation 0.15 |
Secondary
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50
RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).
Time frame: Baseline, Week 50
Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naïve | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50 | -3.69 units on a scale | Standard Deviation 3.76 |
| Rollover (Pre-Placebo) | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50 | -5.50 units on a scale | Standard Deviation 5.64 |
| Rollover (Pre-Duloxetine 60 mg) | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50 | -3.29 units on a scale | Standard Deviation 4.56 |
Secondary
Number of Participants With Fall Events From Fall Questionnaire
Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) \* 100.
Time frame: Week 53
Population: All the enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Naïve | Number of Participants With Fall Events From Fall Questionnaire | 13 participants |
| Rollover (Pre-Placebo) | Number of Participants With Fall Events From Fall Questionnaire | 5 participants |
| Rollover (Pre-Duloxetine 60 mg) | Number of Participants With Fall Events From Fall Questionnaire | 6 participants |
Secondary
Patient Global Impression of Improvement (PGI-Improvement) to Week 50
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).
Time frame: Week 50
Population: FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naïve | Patient Global Impression of Improvement (PGI-Improvement) to Week 50 | 2.12 units on a scale | Standard Deviation 0.88 |
| Rollover (Pre-Placebo) | Patient Global Impression of Improvement (PGI-Improvement) to Week 50 | 2.05 units on a scale | Standard Deviation 0.82 |
| Rollover (Pre-Duloxetine 60 mg) | Patient Global Impression of Improvement (PGI-Improvement) to Week 50 | 2.61 units on a scale | Standard Deviation 1.16 |