Duloxetine Versus Placebo for Osteoarthritis Knee Pain | NCT00408421

ID	Type	Description	Link
F1J-MC-HMEP

Label	Type	Description	Intervention Names
A	Experimental	duloxetine 30 mg, daily (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 6 weeks then duloxetine 60 mg or 120 mg QD, PO for 6 weeks	Drug: Duloxetine
B	Placebo Comparator	placebo daily (QD), by mouth (PO) for 13 weeks	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine	Drug		A	LY248686 Cymbalta
placebo

Measure	Description	Time Frame
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary	This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).	Over 13 Weeks

Measure	Description	Time Frame
Patient Global Impression of Improvement at 13 Week Endpoint	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).	13 Weeks
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Chandler	Arizona	85225

PubMed Identifier	Type	Citation	Retractions
31505082	Derived	Yue L, Wang J, Enomoto H, Fujikoshi S, Alev L, Cheng YY, Skljarevski V. The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain? Pain Pract. 2020 Feb;20(2):129-137. doi: 10.1111/papr.12835. Epub 2019 Nov 20.
24650448	Derived	Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.

ID	Title	Description
FG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
FG001	Duloxetine 60 mg	Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary

This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).

Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.

Posted

Least Squares Mean

Standard Error

units on a scale

Over 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants	OG000119 OG001103

Title

Denominators

Categories

Week 1 (Change from Baseline): N=119, N=103

Title	Measurements
	OG000-0.36± 0.15 OG001-0.84± 0.16

Week 2 (Change from Baseline): N=112, N=101

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).	Mixed-Effects Model Repeated Measures	No adjustments for multiple comparisons were made.	<0.001	P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.						95

Secondary

Patient Global Impression of Improvement at 13 Week Endpoint

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).

Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.

Posted

Least Squares Mean

Standard Error

units on a scale

13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants

Secondary

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale

The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale

The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale

The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score

The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Weekly Change From Baseline in the 24-Hour Worst Pain Score

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.

Posted

Least Squares Mean

Standard Error

units on a scale

Over 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants

Secondary

Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.

Analysis was conducted on an intent-to-treat basis in the re-randomized patients. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Group 2 - Duloxetine 60mg
OG001	Group 3 - Duloxetine 120mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score

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

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score

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

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score

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

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score

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

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity

A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood

A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability

A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work

A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People

A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep

A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life

A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts

Secondary

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference

A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings

Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).

Posted

Number

participants who responded

Over 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase

Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.

Number of re-randomized patients with non-missing response values.

Posted

Number

participants who responded

Over 13 Weeks

ID	Title	Description
OG000	Group 2 - Duloxetine 60mg
OG001	Group 3 - Duloxetine 120mg

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary

A self-reported questionnaire that consists of 36 questions covering 8 health domains. 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. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary

A self-reported questionnaire that consists of 36 questions covering 8 health domains. 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. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score

The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

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

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.'

Posted

Mean

Standard Deviation

units on a scale

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Secondary

Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase

Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.

Posted

Mean

Standard Deviation

Units/Liter

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants

Secondary

Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid

Change from baseline to endpoint in uric acid using central laboratory reference ranges.

Posted

Mean

Standard Deviation

micromole/Liter

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants

Secondary

Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate

Pulse rate (heart rate) measured in the sitting position.

Posted

Mean

Standard Deviation

beats per minute

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants

Secondary

Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic

Diastolic blood pressure measured in the sitting position.

Posted

Mean

Standard Deviation

mm Hg

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants

Secondary

Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic

Systolic blood pressure measured in the sitting position.

Posted

Mean

Standard Deviation

mm Hg

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants

Secondary

Change From Baseline to 13 Week Endpoint in Vital Signs - Weight

Posted

Mean

Standard Deviation

kilograms

Baseline and 13 Weeks

ID	Title	Description
OG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
OG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Palpitations	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Vision blurred	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0012 events2 affected111 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0011 events1 affected111 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0014 events4 affected111 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected120 at risk EG0017 events5 affected111 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0012 events2 affected111 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0012 events2 affected111 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0017 events7 affected111 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Toothache	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0013 events2 affected111 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Chills	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Condition aggravated	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0018 events7 affected111 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0012 events2 affected111 at risk
Pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Swelling	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Seasonal allergy	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0010 events0 affected111 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Fungal infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Molluscum contagiosum	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Oral herpes	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0011 events1 affected111 at risk
Viral infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0010 events0 affected111 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected120 at risk EG0011 events1 affected111 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0012 events2 affected111 at risk
Blood creatinine increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Blood phosphorus decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Blood pressure increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Blood uric acid increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Liver function test abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Weight decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0013 events3 affected111 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Gout	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0010 events0 affected111 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected120 at risk EG0011 events1 affected111 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0010 events0 affected111 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0011 events1 affected111 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0012 events1 affected111 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 events1 affected120 at risk EG0010 events0 affected111 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Disturbance in attention	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected120 at risk EG0014 events4 affected111 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0013 events3 affected111 at risk
Hypersomnia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0010 events0 affected111 at risk
Judgement impaired	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Lethargy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0012 events1 affected111 at risk
Memory impairment	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Migraine	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0011 events1 affected111 at risk
Nerve compression	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Poor quality sleep	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Sciatica	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Serotonin syndrome	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Sinus headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected120 at risk EG0010 events0 affected111 at risk
Somnolence	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0015 events5 affected111 at risk
Agitation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Anxiety	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Apathy	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0002 events1 affected120 at risk EG0010 events0 affected111 at risk
Disorientation	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Emotional disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Euphoric mood	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0003 events2 affected120 at risk EG0015 events3 affected111 at risk
Libido decreased	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0014 events4 affected111 at risk
Mood altered	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Nightmare	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Sleep disorder	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Tearfulness	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Dysuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Micturition disorder	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0013 events3 affected111 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0012 events2 affected111 at risk
Ejaculation disorder	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Sexual dysfunction	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0010 events0 affected111 at risk
Rhinitis seasonal	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 events2 affected120 at risk EG0010 events0 affected111 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0011 events1 affected111 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Nail operation	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Oral surgery	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Hot flush	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0014 events4 affected111 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo			2		49
EG001	Duloxetine 60/120 mg QD	Duloxetine 60/120 mg QD			1		55

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Placebo	placebo daily (QD), by mouth (PO) for 13 weeks
BG001	Duloxetine 60mg /120mg	Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
BG002	Total	Total of all reporting groups

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected120 at risk EG0010 events0 affected111 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected120 at risk EG0011 events1 affected111 at risk