Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00433290
First received: February 7, 2007
Last updated: August 26, 2009
Last verified: August 2009
Results First Received: April 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoarthritis Knee Pain
Interventions: Drug: Duloxetine
Drug: Placebo

  Participant Flow
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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
No text entered.

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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
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] Body mass index is an estimate of body fat based on body weight divided by height squared.
[2] 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).
[3] 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.
[4] This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represents the weekly mean of the scores of the average pain severity over the last 24 hours.



  Outcome Measures
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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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00433290     History of Changes
Other Study ID Numbers: 11198, F1J-MC-HMFG
Study First Received: February 7, 2007
Results First Received: April 30, 2009
Last Updated: August 26, 2009
Health Authority: United States: Food and Drug Administration