Duloxetine Versus Placebo in Chronic Low Back Pain

Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00424593

Enrollment

236

Registered

2007-01-19

Start date

2007-01-31

Completion date

2008-10-31

Last updated

2009-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain Without Radiation

Brief summary

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily can help patients with Chronic Low Back Pain. Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.

Interventions

DRUGDuloxetine

30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase

DRUGPlacebo

every day (QD), by mouth (PO), 13 weeks

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male/Female outpatients 18 years of age with chronic low back pain * Females of child bearing potential must test negative on a pregnancy test at visit 1.

Exclusion criteria

* Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness * Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions * Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study * Have acute liver injury (such as hepatitis) or severe cirrhosis * Have had previous exposure to duloxetine * Have a body mass index (BMI) over 40 * Have a major depressive disorder * Require daily narcotics * Have suicidal risk * Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores	Baseline, Week 13	A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Secondary

Measure	Time frame	Description
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Baseline, Week 13, Week 54	—
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Baseline, Week 13, Week 54	—
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	Baseline, Week 13, Week 54	—
Patient's Global Impression of Improvement (PGI-I)	Week 13	A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	Baseline, Week 13, Week 54	Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Baseline, Week 13	24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.
Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Baseline, Week 13, Week 54	BPI-S and BPI-I are self-reported scales 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 to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Baseline, Week 13, Week 54	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 Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria	Week 13	Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria	Week 13	Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Baseline, Week 13, Week 54	Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Baseline, Week 13	The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)	Baseline, Week 13	The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Baseline, Week 13, Week 54	WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment. 1. Absenteeism=(Q2/(Q2+Q4))\100 2. Presenteeism=(Q5/10)\100 3. Work productivity loss=(Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\])\100 4. Activity Impairment=(Q6/10)\100
Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Baseline, Week 13, Week 54	A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Baseline, Week 13	A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate	Baseline, Week 13	—
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid	Baseline, Week 13	—

Other

Measure	Time frame	Description
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase	Week 13 through Week 54	Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.
Serious Adverse Events During the Dose-Blind Extension Phase	Week 13 though Week 54	Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.

Countries

Brazil, France, Germany, Mexico, Netherlands

Participant flow

Participants by arm

Arm	Count
Duloxetine 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase	115
Placebo every day (QD), by mouth (PO), 13 weeks	121
Total	236

Withdrawals & dropouts

Period	Reason	FG000	FG001
Acute Double-Blind Period	Adverse Event	16	7
Acute Double-Blind Period	Lack of Efficacy	0	1
Acute Double-Blind Period	Lost to Follow-up	1	1
Acute Double-Blind Period	Physician Decision	1	2
Acute Double-Blind Period	Protocol Violation	2	2
Acute Double-Blind Period	Withdrawal by Subject	11	10
Dose-Blind Extension Period	Adverse Event	18	0
Dose-Blind Extension Period	Lack of Efficacy	9	0
Dose-Blind Extension Period	Lost to Follow-up	6	0
Dose-Blind Extension Period	Physician Decision	3	0
Dose-Blind Extension Period	Protocol Violation	9	0
Dose-Blind Extension Period	Withdrawal by Subject	19	0

Baseline characteristics

Characteristic	Duloxetine	Placebo	Total
Age Continuous	51.81 years STANDARD_DEVIATION 14.92	51.15 years STANDARD_DEVIATION 13.46	51.47 years STANDARD_DEVIATION 14.16
Body Mass Index (BMI)	27.63 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.42	27.03 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.81	27.33 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.12
Brief Pain Inventory (BPI) Average Pain Score	5.91 units on a scale STANDARD_DEVIATION 1.59	5.96 units on a scale STANDARD_DEVIATION 1.66	5.94 units on a scale STANDARD_DEVIATION 1.62
Duration of Chronic Lower Back Pain Since Onset	8.79 years STANDARD_DEVIATION 8.75	9.54 years STANDARD_DEVIATION 8.6	9.18 years STANDARD_DEVIATION 8.66
Height	165.92 centimeters (cm) STANDARD_DEVIATION 10.39	167.40 centimeters (cm) STANDARD_DEVIATION 11.34	166.68 centimeters (cm) STANDARD_DEVIATION 10.89
Race/Ethnicity African	6 participants	6 participants	12 participants
Race/Ethnicity Caucasian	85 participants	91 participants	176 participants
Race/Ethnicity East Asian	0 participants	2 participants	2 participants
Race/Ethnicity Hispanic	23 participants	21 participants	44 participants
Race/Ethnicity Native American	1 participants	1 participants	2 participants
Region of Enrollment Brazil	25 participants	29 participants	54 participants
Region of Enrollment France	11 participants	12 participants	23 participants
Region of Enrollment Germany	37 participants	35 participants	72 participants
Region of Enrollment Mexico	23 participants	20 participants	43 participants
Region of Enrollment Netherlands	19 participants	25 participants	44 participants
Sex: Female, Male Female	71 Participants	73 Participants	144 Participants
Sex: Female, Male Male	44 Participants	48 Participants	92 Participants
Weight	76.24 kilograms (kg) STANDARD_DEVIATION 14.71	75.89 kilograms (kg) STANDARD_DEVIATION 13.94	76.06 kilograms (kg) STANDARD_DEVIATION 14.29

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	72 / 115	59 / 121
serious Total, serious adverse events	5 / 115	1 / 121

Outcome results

Primary

Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores

A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Time frame: Baseline, Week 13

Population: Number of participants with baseline and at least one non-missing post-baseline value.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores	-2.32 units on a scale	Standard Error 0.22
Placebo	Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores	-1.50 units on a scale	Standard Error 0.21

p-value: 0.004Repeated Measures Analysis

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale

Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.

Time frame: Baseline, Week 13, Week 54

Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 13 Baseline	8.03 units on a scale	Standard Deviation 4.63
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 13 Change from Baseline	-2.01 units on a scale	Standard Deviation 4.62
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 54 Baseline (n=71, n=86)	5.42 units on a scale	Standard Deviation 4.44
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 54 Change from Baseline (n=71, n=86)	-0.37 units on a scale	Standard Deviation 4.32
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 54 Change from Baseline (n=71, n=86)	-1.05 units on a scale	Standard Deviation 4.49
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 13 Baseline	8.29 units on a scale	Standard Deviation 5.26
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 54 Baseline (n=71, n=86)	6.70 units on a scale	Standard Deviation 5.05
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale	Week 13 Change from Baseline	-1.50 units on a scale	Standard Deviation 5.05

p-value: 0.329ANCOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores

A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Time frame: Baseline, Week 13, Week 54

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 13 Baseline	6.94 units on a scale	Standard Deviation 7.73
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 13 Change from Baseline	-0.51 units on a scale	Standard Deviation 5.5
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 54 Baseline (n=80, n=97)	5.93 units on a scale	Standard Deviation 7.18
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 54 Change from Baseline (n=80, n=97)	-0.64 units on a scale	Standard Deviation 3.98
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 54 Change from Baseline (n=80, n=97)	-1.01 units on a scale	Standard Deviation 6.59
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 13 Baseline	6.81 units on a scale	Standard Deviation 6.77
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 54 Baseline (n=80, n=97)	7.69 units on a scale	Standard Deviation 9.01
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores	Week 13 Change from Baseline	0.68 units on a scale	Standard Deviation 6.81

p-value: 0.177ANCOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores

BPI-S and BPI-I are self-reported scales 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 13, Week 54

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 13 Baseline	5.42 units on a scale	Standard Deviation 2.12
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 13 Change from Baseline	-2.55 units on a scale	Standard Deviation 2.31
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 54 Baseline (n=80, n=97)	4.49 units on a scale	Standard Deviation 2.14
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 54 Change from Baseline	-1.31 units on a scale	Standard Deviation 2.43
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 13 Baseline	4.22 units on a scale	Standard Deviation 2.33
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 13 Change from Baseline	-1.72 units on a scale	Standard Deviation 2.05
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 54 Baseline (n=80, n=97)	2.36 units on a scale	Standard Deviation 1.98
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 54 Change from Baseline	-0.81 units on a scale	Standard Deviation 1.67
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 13 Baseline	5.91 units on a scale	Standard Deviation 1.61
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 13 Change from Baseline	-2.08 units on a scale	Standard Deviation 2.14
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 54 Baseline (n=80, n=97)	3.40 units on a scale	Standard Deviation 1.87
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 54 Change from Baseline	-1.05 units on a scale	Standard Deviation 1.79
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 13 Baseline	7.43 units on a scale	Standard Deviation 1.34
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 13 Change from Baseline	-2.29 units on a scale	Standard Deviation 2.41
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 54 Baseline (n=80, n=97)	2.75 units on a scale	Standard Deviation 1.96
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 54 Change from Baseline	-0.76 units on a scale	Standard Deviation 2.01
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 13 Baseline	5.07 units on a scale	Standard Deviation 2.26
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 13 Change from Baseline	-1.83 units on a scale	Standard Deviation 2.57
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 54 Baseline (n=80, n=97)	3.11 units on a scale	Standard Deviation 2.34
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 54 Change from Baseline	-0.86 units on a scale	Standard Deviation 2.1
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 13 Baseline	3.89 units on a scale	Standard Deviation 2.56
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 13 Change from Baseline	-1.70 units on a scale	Standard Deviation 2.73
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 54 Baseline (n=80, n=97)	1.89 units on a scale	Standard Deviation 2.33
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 54 Change from Baseline	-0.44 units on a scale	Standard Deviation 2.19
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 13 Baseline	4.49 units on a scale	Standard Deviation 2.66
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 13 Change from Baseline	-2.01 units on a scale	Standard Deviation 2.91
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 54 Baseline (n=80, n=97)	2.49 units on a scale	Standard Deviation 2.61
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 54 Change from Baseline	-0.51 units on a scale	Standard Deviation 2.14
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 13 Baseline	5.01 units on a scale	Standard Deviation 2.39
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 13 Change from Baseline	-2.10 units on a scale	Standard Deviation 2.66
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 54 Baseline (n=80, n=97)	2.85 units on a scale	Standard Deviation 2.49
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 54 Change from Baseline	-0.71 units on a scale	Standard Deviation 2.18
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 13 Baseline	2.75 units on a scale	Standard Deviation 2.57
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 13 Change from Baseline	-1.28 units on a scale	Standard Deviation 2.76
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 54 Baseline (n=80,n=97)	1.48 units on a scale	Standard Deviation 1.99
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 54 Change from Baseline	-0.51 units on a scale	Standard Deviation 1.44
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 13 Baseline	4.12 units on a scale	Standard Deviation 2.81
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 13 Change from Baseline	-1.66 units on a scale	Standard Deviation 3.19
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 54 Baseline (n=80, n=97)	2.38 units on a scale	Standard Deviation 2.38
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 54 Change from Baseline	-1.13 units on a scale	Standard Deviation 2.31
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 13 Baseline	3.57 units on a scale	Standard Deviation 2.84
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 13 Change from Baseline	-1.72 units on a scale	Standard Deviation 2.82
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 54 Baseline (n=80, n=97)	1.61 units on a scale	Standard Deviation 2.22
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 54 Change from Baseline	-0.70 units on a scale	Standard Deviation 2.03
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 13 Baseline	4.13 units on a scale	Standard Deviation 1.92
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 13 Change from Baseline	-1.76 units on a scale	Standard Deviation 2.04
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 54 Baseline (n=80, n=97)	2.26 units on a scale	Standard Deviation 1.86
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 54 Change from Baseline	-0.69 units on a scale	Standard Deviation 1.39
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 54 Baseline (n=80, n=97)	3.31 units on a scale	Standard Deviation 2.34
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 13 Baseline	7.34 units on a scale	Standard Deviation 1.46
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 13 Baseline	4.83 units on a scale	Standard Deviation 2.76
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 13 Change from Baseline	-1.72 units on a scale	Standard Deviation 2.25
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 13 Baseline	4.59 units on a scale	Standard Deviation 2.64
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 54 Baseline (n=80, n=97)	5.67 units on a scale	Standard Deviation 2.38
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 13 Change from Baseline	-1.34 units on a scale	Standard Deviation 2.94
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Worst Pain Score Week 54 Change from Baseline	-1.78 units on a scale	Standard Deviation 2.56
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 54 Baseline (n=80, n=97)	2.61 units on a scale	Standard Deviation 2.91
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 13 Baseline	4.22 units on a scale	Standard Deviation 2.42
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 54 Baseline (n=80, n=97)	3.53 units on a scale	Standard Deviation 2.83
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 13 Change from Baseline	-0.83 units on a scale	Standard Deviation 2.16
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 13 Change from Baseline	-1.30 units on a scale	Standard Deviation 3.01
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 54 Baseline (n=80, n=97)	3.33 units on a scale	Standard Deviation 2.6
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Walking Ability Week 54 Change from Baseline	-1.27 units on a scale	Standard Deviation 2.62
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Least Pain Score Week 54 Change from Baseline	-0.93 units on a scale	Standard Deviation 2.21
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 13 Change from Baseline	-1.21 units on a scale	Standard Deviation 2.39
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 13 Baseline	5.93 units on a scale	Standard Deviation 1.67
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 13 Baseline	5.39 units on a scale	Standard Deviation 2.39
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 13 Change from Baseline	-1.43 units on a scale	Standard Deviation 2.25
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 54 Baseline (n=80, n=97)	3.40 units on a scale	Standard Deviation 2.81
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 54 Baseline (n=80, n=97)	4.45 units on a scale	Standard Deviation 2.29
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 13 Change from Baseline	-1.58 units on a scale	Standard Deviation 3.12
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Pain Score Week 54 Change from Baseline	-1.35 units on a scale	Standard Deviation 2.24
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 54 Change from Baseline	-0.93 units on a scale	Standard Deviation 2.33
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 13 Baseline	5.55 units on a scale	Standard Deviation 2.05
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 54 Baseline (n=80, n=97)	3.81 units on a scale	Standard Deviation 2.72
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 13 Change from Baseline	-1.43 units on a scale	Standard Deviation 2.53
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Sleep Week 54 Change from Baseline	-1.08 units on a scale	Standard Deviation 2.38
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 54 Baseline (n=80, n=97)	4.11 units on a scale	Standard Deviation 2.58
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Normal Work Week 54 Change from Baseline	-1.09 units on a scale	Standard Deviation 2.32
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Pain Right Now Score Week 54 Change from Baseline	-1.25 units on a scale	Standard Deviation 2.48
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 54 Change from Baseline	-1.06 units on a scale	Standard Deviation 1.96
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 13 Baseline	5.60 units on a scale	Standard Deviation 2.29
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 13 Baseline	3.39 units on a scale	Standard Deviation 2.91
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 13 Change from Baseline	-1.51 units on a scale	Standard Deviation 2.86
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 13 Baseline	3.41 units on a scale	Standard Deviation 2.74
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 54 Baseline (n=80, n=97)	4.05 units on a scale	Standard Deviation 2.78
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 13 Change from Baseline	-0.92 units on a scale	Standard Deviation 3.37
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	General Activity Week 54 Change from Baseline	-1.32 units on a scale	Standard Deviation 2.78
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Average Interference Week 13 Baseline	4.50 units on a scale	Standard Deviation 2.08
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 13 Baseline	4.30 units on a scale	Standard Deviation 2.76
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 54 Baseline (n=80,n=97)	2.53 units on a scale	Standard Deviation 2.69
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 13 Change from Baseline	-1.03 units on a scale	Standard Deviation 3.24
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Enjoyment of Life Week 13 Change from Baseline	-0.81 units on a scale	Standard Deviation 2.96
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 54 Baseline (n=80, n=97)	3.24 units on a scale	Standard Deviation 3
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Relations With People Week 54 Change from Baseline	-0.77 units on a scale	Standard Deviation 2.57
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores	Mood Week 54 Change from Baseline	-0.93 units on a scale	Standard Deviation 2.69

p-value: 0.011ANCOVA

p-value: 0.001ANCOVA

p-value: 0.019ANCOVA

p-value: 0.002ANCOVA

p-value: 0.068ANCOVA

p-value: 0.009ANCOVA

p-value: 0.006ANCOVA

p-value: 0.024ANCOVA

p-value: 0.005ANCOVA

p-value: 0.051ANCOVA

p-value: 0.013ANCOVA

p-value: 0.005ANCOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)

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).

Time frame: Baseline, Week 13, Week 54

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 13 Baseline	3.23 units on a scale	Standard Deviation 1.51
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 13 Change from Baseline	-0.94 units on a scale	Standard Deviation 1.29
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 54 Baseline (n=81, n=97)	2.21 units on a scale	Standard Deviation 1.15
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 54 Change from Baseline (n=81, n=97)	-0.23 units on a scale	Standard Deviation 0.84
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 54 Change from Baseline (n=81, n=97)	-0.52 units on a scale	Standard Deviation 1.08
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 13 Baseline	3.27 units on a scale	Standard Deviation 1.45
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 54 Baseline (n=81, n=97)	2.60 units on a scale	Standard Deviation 1.27
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)	Week 13 Change from Baseline	-0.74 units on a scale	Standard Deviation 1.22

p-value: 0.092ANCOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score

Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).

Time frame: Baseline, Week 13, Week 54

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	13 Week Baseline	10.39 units on a scale	Standard Deviation 4.78
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	13 Week Change from Baseline	-3.13 units on a scale	Standard Deviation 4.65
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	54 Week Baseline (n=59, n=82)	7.83 units on a scale	Standard Deviation 5.75
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	54 Week Change from Baseline (n=59, n=82)	-1.14 units on a scale	Standard Deviation 3.51
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	54 Week Change from Baseline (n=59, n=82)	-2.40 units on a scale	Standard Deviation 5.3
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	13 Week Baseline	10.87 units on a scale	Standard Deviation 5.12
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	54 Week Baseline (n=59, n=82)	9.59 units on a scale	Standard Deviation 6.11
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score	13 Week Change from Baseline	-1.53 units on a scale	Standard Deviation 4.85

p-value: 0.009ANCOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure

Time frame: Baseline, Week 13, Week 54

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	Systolic Blood Pressure (SBP) Week 13 Baseline	127.44 mm Hg	Standard Deviation 14.4
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	SBP Week 13 Change from Baseline	-0.94 mm Hg	Standard Deviation 11.12
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	SBP Week 54 Baseline (n=76, n=90)	127.04 mm Hg	Standard Deviation 14.1
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	SBP Week 54 Change from Baseline	-1.42 mm Hg	Standard Deviation 14.4
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	Diastolic Blood Pressure (DBP) Week 13 Baseline	79.92 mm Hg	Standard Deviation 8.63
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	DBP Week 13 Change from Baseline	0.32 mm Hg	Standard Deviation 8.27
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	DBP Week 54 Baseline (n=76, n=90)	81.53 mm Hg	Standard Deviation 8.19
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	DBP Week 54 Change from Baseline	-2.00 mm Hg	Standard Deviation 9.37
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	DBP Week 54 Change from Baseline	0.50 mm Hg	Standard Deviation 8.02
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	Systolic Blood Pressure (SBP) Week 13 Baseline	127.62 mm Hg	Standard Deviation 14.75
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	Diastolic Blood Pressure (DBP) Week 13 Baseline	80.38 mm Hg	Standard Deviation 8.36
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	SBP Week 13 Change from Baseline	-1.24 mm Hg	Standard Deviation 13.3
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	DBP Week 54 Baseline (n=76, n=90)	79.74 mm Hg	Standard Deviation 8.74
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	SBP Week 54 Baseline (n=76, n=90)	127.07 mm Hg	Standard Deviation 14.99
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	DBP Week 13 Change from Baseline	-1.25 mm Hg	Standard Deviation 7.47
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure	SBP Week 54 Change from Baseline	0.77 mm Hg	Standard Deviation 12.98

p-value: 0.764ANOVA

p-value: 0.093ANOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate

Time frame: Baseline, Week 13, Week 54

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 13 Baseline	72.21 beats per minute (bpm)	Standard Deviation 8.9
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 13 Change from Baseline	2.05 beats per minute (bpm)	Standard Deviation 10.6
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 54 Baseline (n=76, n=90)	74.95 beats per minute (bpm)	Standard Deviation 10.16
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 54 Change from Baseline	-2.46 beats per minute (bpm)	Standard Deviation 10.52
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 54 Change from Baseline	1.46 beats per minute (bpm)	Standard Deviation 7.47
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 13 Baseline	72.31 beats per minute (bpm)	Standard Deviation 9.97
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 54 Baseline (n=76, n=90)	71.03 beats per minute (bpm)	Standard Deviation 7.56
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate	Week 13 Change from Baseline	-0.90 beats per minute (bpm)	Standard Deviation 10.67

p-value: 0.028ANOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight

Time frame: Baseline, Week 13, Week 54

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 13 Baseline	76.63 kilograms (kg)	Standard Deviation 14.83
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 13 Change from Baseline	-0.64 kilograms (kg)	Standard Deviation 2.32
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 54 Baseline (n=81, n=97)	76.57 kilograms (kg)	Standard Deviation 14.61
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 54 Change from Baseline	1.42 kilograms (kg)	Standard Deviation 3.25
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 54 Change from Baseline	-0.38 kilograms (kg)	Standard Deviation 2.46
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 13 Baseline	76.29 kilograms (kg)	Standard Deviation 14.01
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 54 Baseline (n=81, n=97)	75.34 kilograms (kg)	Standard Deviation 13.42
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight	Week 13 Change from Baseline	0.08 kilograms (kg)	Standard Deviation 1.97

p-value: 0.008ANOVA

Secondary

Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment. 1. Absenteeism=(Q2/(Q2+Q4))\*100 2. Presenteeism=(Q5/10)\*100 3. Work productivity loss=(Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))x(Q5/10)\])\*100 4. Activity Impairment=(Q6/10)\*100

Time frame: Baseline, Week 13, Week 54

Population: Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 13 Baseline (n=35, n=32)	0.17 units on a scale	Standard Deviation 0.3
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 13 Change from Baseline	-0.14 units on a scale	Standard Deviation 0.29
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 54 Baseline (n=24, n=32)	0.03 units on a scale	Standard Deviation 0.1
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 54 Change from Baseline	0.01 units on a scale	Standard Deviation 0.12
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 13 Baseline (n=37, n=31)	0.42 units on a scale	Standard Deviation 0.3
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 13 Change from Baseline	-0.17 units on a scale	Standard Deviation 0.32
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 54 Baseline (n=24, n=34)	0.19 units on a scale	Standard Deviation 0.16
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 54 Change from Baseline	-0.05 units on a scale	Standard Deviation 0.2
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 13 Baseline(n=33,n=29)	0.47 units on a scale	Standard Deviation 0.31
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 13 Change	-0.19 units on a scale	Standard Deviation 0.3
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 54 Baseline(n=24,n=32)	0.21 units on a scale	Standard Deviation 0.19
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 54 Change	-0.04 units on a scale	Standard Deviation 0.22
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 13 Baseline (n=103,n=105)	0.54 units on a scale	Standard Deviation 0.23
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 13 Change from Baseline	-0.20 units on a scale	Standard Deviation 0.29
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 54 Baseline (n=70, n=86)	0.32 units on a scale	Standard Deviation 0.24
Duloxetine	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 54 Change from Baseline	-0.06 units on a scale	Standard Deviation 0.2
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 54 Change from Baseline	-0.16 units on a scale	Standard Deviation 0.22
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 13 Baseline (n=35, n=32)	0.05 units on a scale	Standard Deviation 0.1
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 13 Baseline(n=33,n=29)	0.38 units on a scale	Standard Deviation 0.18
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 13 Change from Baseline	0.03 units on a scale	Standard Deviation 0.2
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 13 Baseline (n=103,n=105)	0.57 units on a scale	Standard Deviation 0.22
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 54 Baseline (n=24, n=32)	0.02 units on a scale	Standard Deviation 0.07
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 13 Change	-0.06 units on a scale	Standard Deviation 0.21
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Absenteeism Score Week 54 Change from Baseline	0.01 units on a scale	Standard Deviation 0.14
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 54 Baseline (n=70, n=86)	0.45 units on a scale	Standard Deviation 0.27
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 13 Baseline (n=37, n=31)	0.36 units on a scale	Standard Deviation 0.19
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 54 Baseline(n=24,n=32)	0.32 units on a scale	Standard Deviation 0.26
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 13 Change from Baseline	-0.06 units on a scale	Standard Deviation 0.21
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Activity Impairment Week 13 Change from Baseline	-0.11 units on a scale	Standard Deviation 0.25
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 54 Baseline (n=24, n=34)	0.30 units on a scale	Standard Deviation 0.25
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Work Productivity Loss Week 54 Change	-0.13 units on a scale	Standard Deviation 0.19
Placebo	Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores	Presenteeism Score Week 54 Change from Baseline	-0.13 units on a scale	Standard Deviation 0.17

p-value: 0.063ANCOVA

p-value: 0.452ANCOVA

p-value: 0.736ANCOVA

p-value: 0.002ANCOVA

Secondary

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.

Time frame: Baseline, Week 13

Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Component Summary Baseline	49.69 units on a scale	Standard Deviation 9.99
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Component Summary Change from Baseline	2.05 units on a scale	Standard Deviation 9.9
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Component Summary Baseline	33.39 units on a scale	Standard Deviation 7.61
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Component Summary Change from Baseline	5.69 units on a scale	Standard Deviation 9.17
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Bodily Pain Baseline	5.48 units on a scale	Standard Deviation 1.38
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Bodily Pain Change from Baseline	1.55 units on a scale	Standard Deviation 2.04
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	General Health Baseline	16.27 units on a scale	Standard Deviation 4
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	General Health Change from Baseline	1.73 units on a scale	Standard Deviation 3.57
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Health Baseline	22.06 units on a scale	Standard Deviation 4.51
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Health Change from Baseline	1.19 units on a scale	Standard Deviation 4.12
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Functioning Baseline	19.53 units on a scale	Standard Deviation 4.26
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Functioning Change from Baseline	2.59 units on a scale	Standard Deviation 4.51
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Emotional Baseline	4.57 units on a scale	Standard Deviation 1.29
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Emotional Change from Baseline	0.44 units on a scale	Standard Deviation 1.41
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Physical Baseline	5.24 units on a scale	Standard Deviation 1.41
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Physical Change from Baseline	0.63 units on a scale	Standard Deviation 1.75
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Social Functioning Baseline	7.83 units on a scale	Standard Deviation 1.77
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Social Functioning Change from Baseline	0.51 units on a scale	Standard Deviation 1.93
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Vitality Baseline	15.16 units on a scale	Standard Deviation 3.33
Duloxetine	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Vitality Change from Baseline	1.08 units on a scale	Standard Deviation 3.93
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Social Functioning Change from Baseline	0.14 units on a scale	Standard Deviation 2.08
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Component Summary Baseline	49.60 units on a scale	Standard Deviation 11.11
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Functioning Baseline	19.87 units on a scale	Standard Deviation 4.31
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Component Summary Change from Baseline	-0.49 units on a scale	Standard Deviation 10.45
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Physical Change from Baseline	0.48 units on a scale	Standard Deviation 1.63
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Component Summary Baseline	32.62 units on a scale	Standard Deviation 7.37
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Functioning Change from Baseline	1.61 units on a scale	Standard Deviation 4.26
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Physical Component Summary Change from Baseline	4.12 units on a scale	Standard Deviation 8.97
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Vitality Change from Baseline	0.21 units on a scale	Standard Deviation 4.31
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Bodily Pain Baseline	5.42 units on a scale	Standard Deviation 1.39
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Emotional Baseline	4.67 units on a scale	Standard Deviation 1.31
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Bodily Pain Change from Baseline	0.95 units on a scale	Standard Deviation 1.91
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Social Functioning Baseline	7.57 units on a scale	Standard Deviation 1.98
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	General Health Baseline	15.75 units on a scale	Standard Deviation 4.03
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Emotional Change from Baseline	0.12 units on a scale	Standard Deviation 1.37
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	General Health Change from Baseline	0.82 units on a scale	Standard Deviation 4.08
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Vitality Baseline	14.79 units on a scale	Standard Deviation 3.69
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Health Baseline	21.95 units on a scale	Standard Deviation 4.52
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Role-Physical Baseline	5.07 units on a scale	Standard Deviation 1.33
Placebo	Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)	Mental Health Change from Baseline	0.28 units on a scale	Standard Deviation 4.58

p-value: 0.051ANCOVA

p-value: 0.22ANCOVA

p-value: 0.038ANCOVA

p-value: 0.041ANCOVA

p-value: 0.093ANCOVA

p-value: 0.21ANCOVA

p-value: 0.17ANCOVA

p-value: 0.306ANCOVA

p-value: 0.053ANCOVA

p-value: 0.04ANCOVA

Secondary

Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)

The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.

Time frame: Baseline, Week 13

Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)	Baseline	0.49 units on a scale	Standard Deviation 0.31
Duloxetine	Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)	Change from Baseline	0.16 units on a scale	Standard Deviation 0.32
Placebo	Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)	Baseline	0.49 units on a scale	Standard Deviation 0.32
Placebo	Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)	Change from Baseline	0.11 units on a scale	Standard Deviation 0.3

p-value: 0.117ANCOVA

Secondary

Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores

A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Time frame: Baseline, Week 13

Population: Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Anxiety Subscale Baseline (n=102, n=104)	4.94 units on a scale	Standard Deviation 3.76
Duloxetine	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Anxiety Subscale Change from Baseline	-0.70 units on a scale	Standard Deviation 3.18
Duloxetine	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Depression Subscale Baseline (n=103, n=105)	3.65 units on a scale	Standard Deviation 3.22
Duloxetine	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Depression Subscale Change from Baseline	-0.27 units on a scale	Standard Deviation 2.58
Placebo	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Depression Subscale Change from Baseline	0.10 units on a scale	Standard Deviation 2.99
Placebo	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Anxiety Subscale Baseline (n=102, n=104)	4.41 units on a scale	Standard Deviation 3.67
Placebo	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Depression Subscale Baseline (n=103, n=105)	3.87 units on a scale	Standard Deviation 3.42
Placebo	Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores	Anxiety Subscale Change from Baseline	0.11 units on a scale	Standard Deviation 3.34

p-value: 0.122ANCOVA

p-value: 0.262ANCOVA

Secondary

Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale

24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.

Time frame: Baseline, Week 13

Population: Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Average Pain Score Baseline	5.94 units on a scale	Standard Deviation 1.36
Duloxetine	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Average Pain Score Change from Baseline	-1.92 units on a scale	Standard Deviation 1.91
Duloxetine	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Worst Pain Score Baseline	6.91 units on a scale	Standard Deviation 1.24
Duloxetine	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Worst Pain Score Change from Baseline	-1.97 units on a scale	Standard Deviation 2.01
Duloxetine	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Night Pain Score Baseline	5.46 units on a scale	Standard Deviation 1.77
Duloxetine	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Night Pain Score Change from Baseline	-1.82 units on a scale	Standard Deviation 2.01
Placebo	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Night Pain Score Baseline	5.50 units on a scale	Standard Deviation 1.81
Placebo	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Average Pain Score Baseline	6.05 units on a scale	Standard Deviation 1.33
Placebo	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Worst Pain Score Change from Baseline	-1.31 units on a scale	Standard Deviation 1.89
Placebo	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Average Pain Score Change from Baseline	-1.16 units on a scale	Standard Deviation 1.95
Placebo	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Night Pain Score Change from Baseline	-1.15 units on a scale	Standard Deviation 1.94
Placebo	Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale	Worst Pain Score Baseline	7.02 units on a scale	Standard Deviation 1.21

p-value: 0.002ANCOVA

p-value: 0.014ANCOVA

p-value: 0.007ANCOVA

Secondary

Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate

Time frame: Baseline, Week 13

Population: Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate	Baseline	24.90 millimole per Liter (mmol/L)	Standard Deviation 2.8
Duloxetine	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate	Change from Baseline	0.57 millimole per Liter (mmol/L)	Standard Deviation 2.89
Placebo	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate	Baseline	25.10 millimole per Liter (mmol/L)	Standard Deviation 2.94
Placebo	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate	Change from Baseline	-0.28 millimole per Liter (mmol/L)	Standard Deviation 2.84

p-value: 0.046ANOVA

Secondary

Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid

Time frame: Baseline, Week 13

Population: Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward.

Arm	Measure	Group	Value (MEAN)	Dispersion
Duloxetine	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid	Baseline	303.23 micromole per Liter (μmol/L)	Standard Deviation 79.04
Duloxetine	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid	Change from Baseline	-6.27 micromole per Liter (μmol/L)	Standard Deviation 37.81
Placebo	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid	Baseline	298.07 micromole per Liter (μmol/L)	Standard Deviation 82.63
Placebo	Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid	Change from Baseline	8.68 micromole per Liter (μmol/L)	Standard Deviation 43.72

p-value: 0.008ANOVA

Secondary

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria

Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.

Time frame: Week 13

Population: Number of randomized participants with non-missing response values.

Arm	Measure	Value (NUMBER)
Duloxetine	Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria	58 participants
Placebo	Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria	46 participants

p-value: 0.06Fisher Exact

Secondary

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria

Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.

Time frame: Week 13

Population: Number of randomized participants with non-missing response values.

Arm	Measure	Value (NUMBER)
Duloxetine	Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria	42 participants
Placebo	Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria	31 participants

p-value: 0.087Fisher Exact

Secondary

Patient's Global Impression of Improvement (PGI-I)

A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).

Time frame: Week 13

Population: Number of participants with at least one non-missing post-baseline value. Last observation carried forward.

Arm	Measure	Value (MEAN)	Dispersion
Duloxetine	Patient's Global Impression of Improvement (PGI-I)	2.81 units on a scale	Standard Deviation 1.18
Placebo	Patient's Global Impression of Improvement (PGI-I)	3.23 units on a scale	Standard Deviation 1.26

p-value: 0.014ANCOVA

Other Pre-specified

Serious Adverse Events During the Dose-Blind Extension Phase

Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.

Time frame: Week 13 though Week 54

Population: Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.

Arm	Measure	Group	Value (NUMBER)
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Patients with ≥1 Serious Adverse Event	9 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Accidental overdose	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Acute tonsillitis	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Angiopathy	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Back pain	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Femur fracture	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Hand fracture	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Osteoarthritis	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Road traffic accident	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Suicidal ideation	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Syncope	1 participants
Duloxetine	Serious Adverse Events During the Dose-Blind Extension Phase	Tonsillitis	1 participants

Other Pre-specified

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase

Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.

Time frame: Week 13 through Week 54

Arm	Measure	Group	Value (NUMBER)
Duloxetine	Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase	Headache	22 participant
Duloxetine	Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase	Nausea	17 participant
Duloxetine	Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase	Abdominal pain upper	13 participant
Duloxetine	Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase	Hyperhidrosis	11 participant

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026

Duloxetine Versus Placebo in Chronic Low Back Pain

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores

Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale

Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores

Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores

Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)

Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate

Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight

Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)

Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)

Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores

Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale

Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate

Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria

Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria

Patient's Global Impression of Improvement (PGI-I)

Serious Adverse Events During the Dose-Blind Extension Phase

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase