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A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01018680
First received: November 23, 2009
Last updated: September 4, 2012
Last verified: September 2012
Results First Received: March 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   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
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Reporting Groups
  Description
Placebo Participants received placebo by mouth, once daily for 10 weeks.
Duloxetine Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.

Participant Flow:   Overall Study
    Placebo     Duloxetine  
STARTED     260     264  
COMPLETED     199     189  
NOT COMPLETED     61     75  
Adverse Event                 23                 40  
Withdrawal by Subject                 10                 10  
Protocol Violation                 5                 8  
Sponsor Decision                 6                 7  
Lack of Efficacy                 8                 2  
Lost to Follow-up                 5                 3  
Entry Criteria Not Met                 1                 4  
Physician Decision                 3                 1  



  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
Placebo Participants received placebo by mouth, once daily for 10 weeks.
Duloxetine Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
Total Total of all reporting groups

Baseline Measures
    Placebo     Duloxetine     Total  
Number of Participants  
[units: participants]
  260     264     524  
Age  
[units: years]
Mean ± Standard Deviation
  60.32  ± 9.17     61.63  ± 9.24     60.98  ± 9.22  
Gender  
[units: participants]
     
Female     147     152     299  
Male     113     112     225  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     3     1     4  
Asian     2     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     46     38     84  
White     206     218     424  
More than one race     2     6     8  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     260     264     524  
Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation
  90.78  ± 17.49     90.41  ± 18.13     90.59  ± 17.80  
Weekly 24-Hour Average Pain Rating [1]
[units: units on a scale]
Mean ± Standard Deviation
  6.36  ± 1.41     6.27  ± 1.41     6.32  ± 1.41  
Brief Pain Inventory-Severity (BPI-S) Average Pain [2]
[units: units on a scale]
Mean ± Standard Deviation
  6.24  ± 1.51     6.09  ± 1.58     6.16  ± 1.54  
Patient Global Assessment of Illness (PGAI) [3]
[units: units on a scale]
Mean ± Standard Deviation
  6.95  ± 1.50     6.93  ± 1.49     6.94  ± 1.49  
Western Ontario and McMaster Universities Index of Osteoarthritis Physical Function Score [4]
[units: units on a scale]
Mean ± Standard Deviation
  37.51  ± 9.39     37.40  ± 10.10     37.45  ± 9.74  
Duration of Osteoarthritis (OA) Pain  
[units: years]
Mean ± Standard Deviation
  9.19  ± 8.92     9.79  ± 8.88     9.49  ± 8.90  
[1] The weekly 24-hour average pain rating was calculated from the participant's daily 24-hour average pain ratings made on an 11-point numeric rating scale, with scores from 0 (indicating "no pain") to 10 (indicating "the worst possible pain") from the week ending at the day of randomization.
[2] The BPI-S is a self-reported scale measuring severity of pain. Severity score ranges from 0 (no pain) to 10 (severe pain) assessing average pain in past 24 hours.
[3] The PGAI is a participant-rated measure of the severity of osteoarthritis (OA) of the knee the participant has experienced in the past week as indicated on an 11-point numeric rating scale, with scores ranging from 0 to 10, where greater numbers reflect greater severity.
[4] The Western Ontario and McMaster Universities Index of Osteoarthritis Physical Function Score (WOMAC; Bellamy et al. 1988) is a self-administered, participant-centered health status questionnaire used to capture the elements of pain, stiffness, and physical disability in participants with osteoarthritis (OA) of the knee and/or hip. The physical function index has 17 questions. Each question uses a 5-point numeric rating scale ranging from 0 (no difficulty) to 4 (extreme difficulty). Physical function scores range from 0 to 68, where higher scores indicate greater impairment.



  Outcome Measures
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1.  Primary:   Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks   [ Time Frame: Baseline, 8 weeks (blinded endpoint) ]

2.  Secondary:   Patient Global Impression of Improvement (PGI-I) at 8 Weeks   [ Time Frame: 8 weeks (blinded endpoint) ]

3.  Secondary:   Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks   [ Time Frame: Baseline, 8 weeks (blinded endpoint) ]

4.  Secondary:   Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks   [ Time Frame: Baseline, 8 weeks (blinded endpoint) ]

5.  Secondary:   Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks   [ Time Frame: Baseline, 8 weeks (blinded endpoint) ]

6.  Secondary:   Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks   [ Time Frame: Baseline, 8 weeks (blinded endpoint) ]

7.  Secondary:   Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks   [ Time Frame: Baseline, 8 weeks (blinded endpoint) ]

8.  Secondary:   Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks   [ Time Frame: Baseline, 8 weeks (blinded endpoint) ]

9.  Secondary:   Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period   [ Time Frame: Baseline through 10 weeks (blinded endpoint) ]

10.  Secondary:   Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks   [ Time Frame: Up to 8 weeks (blinded endpoint) ]

11.  Secondary:   Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Weekly Mean of the 24-Hour Average Pain Score up to 8 Weeks   [ Time Frame: Up to 8 weeks (blinded endpoint) ]

12.  Secondary:   Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Brief Pain Inventory-Severity (BPI-S) Average Pain Score up to 8 Weeks   [ Time Frame: Up to 8 weeks (blinded endpoint) ]

13.  Secondary:   Percentage of Participants Who Discontinued Due to an Adverse Event During the 10-Week Treatment Period   [ Time Frame: Baseline through 10 weeks ]

14.  Other Pre-specified:   Percentage of Participants With Abnormal High Hemoglobin A1c (HbA1c) up to 10 Weeks   [ Time Frame: Up to 10 weeks ]

15.  Other Pre-specified:   Percentage of Participants With Abnormal Weight Gain and Weight Loss up to 10 Weeks   [ Time Frame: Up to 10 weeks ]

16.  Other Pre-specified:   Percentage of Participants With Abnormal Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) up to 10 Weeks   [ Time Frame: Up to 10 weeks ]

17.  Other Pre-specified:   Percentage of Participants With Abnormal Pulse Rate up to 10 Weeks   [ Time Frame: Up to 10 weeks ]

18.  Other Pre-specified:   Percentage of Participants With a Change of Better, Worse, or No Change in Health Outcomes as Measured by Resource Utilization (REU) up to 10 Weeks   [ Time Frame: Up to 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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


Publications:
Publications automatically indexed to this study:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01018680     History of Changes
Other Study ID Numbers: 12909, F1J-US-HMGL
Study First Received: November 23, 2009
Results First Received: March 29, 2012
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration