Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Duloxetine	duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
Placebo	placebo every day (QD), by mouth (PO) for 13 weeks

Participant Flow:   Overall Study

	Duloxetine	Placebo
STARTED	128	128
COMPLETED	93	111
NOT COMPLETED	35	17
Adverse Event	24	7
Lack of Efficacy	1	5
Withdrawal by Subject	4	2
Protocol Violation	3	2
Physician Decision	2	0
Entry Criteria Not Met	0	1
Lost to Follow-up	1	0

Reporting Groups

	Description
Duloxetine	duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
Placebo	placebo every day (QD), by mouth (PO) for 13 weeks
Total	Total of all reporting groups

Baseline Measures

	Duloxetine	Placebo	Total
Number of Participants   [units: participants]	128	128	256
Age   [units: years] Mean ± Standard Deviation	63.16  ± 8.75	61.90  ± 9.20	62.53  ± 8.98
Gender   [units: participants]
Female	89	107	196
Male	39	21	60
Region of Enrollment   [units: participants]
United States	11	10	21
Greece	16	16	32
Russian Federation	62	65	127
Sweden	14	14	28
Canada	25	23	48
Nonsteroidal Anti-Inflammatory Drug (NSAID) Use   [units: participants]
No	81	75	156
Yes	47	53	100
Race/Ethnicity   [units: participants]
African	0	3	3
Caucasian	126	124	250
East Asian	0	1	1
Hispanic	2	0	2
Body Mass Index [1] [units: kilograms/meters squared] Mean ± Standard Deviation	29.44  ± 4.66	29.65  ± 4.52	29.55  ± 4.58
Body Weight   [units: kilograms] Mean ± Standard Deviation	81.05  ± 13.73	80.55  ± 12.24	80.80  ± 12.98
Brief Pain Inventory Average Pain [2] [units: units on a scale] Mean ± Standard Deviation	6.07  ± 1.39	6.14  ± 1.27	6.11  ± 1.33
Clinical Global Impressions of Severity Scale (CGI-S) [3] [units: units on a scale] Mean ± Standard Deviation	3.34  ± 1.21	3.34  ± 1.33	3.34  ± 1.27
Duration of Osteoarthritis Pain Since Onset   [units: years] Mean ± Standard Deviation	8.14  ± 7.64	6.74  ± 6.58	7.44  ± 7.15
Duration of Osteoarthritis Since Diagnosis   [units: years] Mean ± Standard Deviation	6.16  ± 5.88	5.62  ± 6.20	5.89  ± 6.04
Height   [units: centimeters] Mean ± Standard Deviation	165.99  ± 8.69	165.02  ± 7.99	165.51  ± 8.34
Weekly Mean of 24 Hour Average Pain Severity [4] [units: units on a scale] Mean ± Standard Deviation	6.02  ± 1.18	6.07  ± 1.26	6.04  ± 1.22

1.  Primary:

Change in Brief Pain Inventory (BPI) 24-hour Average Rating   [ Time Frame: Baseline, Week 4, Week 7, Week 13 ]

2.  Secondary:

Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)   [ Time Frame: 13 Weeks ]

3.  Secondary:

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale   [ Time Frame: Baseline and 13 Weeks ]

4.  Secondary:

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale   [ Time Frame: Baseline and 13 Weeks ]

5.  Secondary:

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale   [ Time Frame: Baseline and 13 Weeks ]

6.  Secondary:

Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores   [ Time Frame: Baseline and 13 Weeks ]

7.  Secondary:

Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)   [ Time Frame: Baseline and 13 Weeks ]

8.  Secondary:

Number of Participants Who Responded to Treatment at 13 Week Endpoint   [ Time Frame: 13 Weeks ]

9.  Secondary:

Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores   [ Time Frame: Baseline and 13 Weeks ]

10.  Secondary:

Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire – 5 Dimension (EQ-5D)   [ Time Frame: Baseline and 13 Weeks ]

11.  Secondary:

Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)   [ Time Frame: Baseline and 13 Weeks ]

12.  Secondary:

Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)   [ Time Frame: Baseline and 13 Weeks ]

13.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score   [ Time Frame: Baseline and 13 Weeks ]

14.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score   [ Time Frame: Baseline and 13 Weeks ]

15.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score   [ Time Frame: Baseline and 13 Weeks ]

16.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score   [ Time Frame: Baseline and 13 Weeks ]

17.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity   [ Time Frame: Baseline and 13 Weeks ]

18.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood   [ Time Frame: Baseline and 13 Weeks ]

19.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability   [ Time Frame: Baseline and 13 Weeks ]

20.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work   [ Time Frame: Baseline and 13 Weeks ]

21.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People   [ Time Frame: Baseline and 13 Weeks ]

22.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep   [ Time Frame: Baseline and 13 Weeks ]

23.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life   [ Time Frame: Baseline and 13 Weeks ]

24.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference   [ Time Frame: Baseline and 13 Weeks ]

25.  Secondary:

Adverse Events Reported as Reason for Discontinuation   [ Time Frame: over 13 weeks ]

26.  Secondary:

Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes   [ Time Frame: Baseline and 13 Weeks ]

27.  Secondary:

Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride   [ Time Frame: Baseline and 13 Week Endpoint ]

28.  Secondary:

Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate   [ Time Frame: Baseline and 13 Weeks ]

29.  Secondary:

Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure   [ Time Frame: Baseline and 13 Weeks ]

30.  Secondary:

Change From Baseline to 13 Week Endpoint in Vital Signs - Weight   [ Time Frame: Baseline and 13 Weeks ]

31.  Secondary:

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders   [ Time Frame: Baseline and 13 Weeks ]

32.  Secondary:

Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint   [ Time Frame: 13 Weeks ]

33.  Secondary:

Adverse Events Reported as Reason for Discontinuation in Nonresponders   [ Time Frame: over 13 Weeks ]