A Study of Duloxetine in Patients With Osteoarthritis Knee Pain

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00945945
First received: July 23, 2009
Last updated: February 11, 2011
Last verified: February 2011
Results First Received: February 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Osteoarthritis Knee Pain
Interventions: Drug: Duloxetine (DLX)
Drug: Placebo (PLA)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to a study drug labeling error which led to a treatment crossover, the intended comparisons for group-level differences between duloxetine and placebo cannot be made. The results from comparisons of mixed-treatment groups are presented for primary efficacy and safety outcomes.

Reporting Groups
  Description
DLX30-PLA Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
PLA-DLX60 Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.

Participant Flow:   Overall Study
    DLX30-PLA     PLA-DLX60  
STARTED     207     217  
COMPLETED     171     162  
NOT COMPLETED     36     55  
Adverse Event                 15                 35  
Withdrawal by Subject                 7                 10  
Lost to Follow-up                 4                 5  
Lack of Efficacy                 6                 2  
Protocol Violation                 4                 2  
Entry Criteria Not Met                 0                 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.
No text entered.

Reporting Groups
  Description
DLX30-PLA Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
PLA-DLX60 Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
Total Total of all reporting groups

Baseline Measures
    DLX30-PLA     PLA-DLX60     Total  
Number of Participants  
[units: participants]
  207     217     424  
Age  
[units: years]
Mean ± Standard Deviation
  63.40  ± 9.90     64.18  ± 10.06     63.80  ± 9.97  
Gender  
[units: participants]
     
Female     147     141     288  
Male     60     76     136  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     26     27     53  
Not Hispanic or Latino     181     190     371  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     2     0     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     8     13     21  
White     196     203     399  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     81     92     173  
Puerto Rico     3     4     7  
Greece     13     11     24  
Spain     25     23     48  
Romania     16     19     35  
Russian Federation     33     32     65  
Germany     18     19     37  
Sweden     18     17     35  



  Outcome Measures
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1.  Primary:   Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score   [ Time Frame: Baseline, 13 weeks ]

2.  Secondary:   Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale   [ Time Frame: Baseline through 13 weeks ]

3.  Secondary:   Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score   [ Time Frame: Baseline, 13 weeks ]

4.  Secondary:   Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score   [ Time Frame: baseline, 13 weeks ]

5.  Secondary:   Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale   [ Time Frame: Baseline, 13 weeks ]

6.  Secondary:   Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score   [ Time Frame: Baseline, 13 weeks ]

7.  Secondary:   Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S)   [ Time Frame: Baseline, 13 weeks ]

8.  Secondary:   Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version   [ Time Frame: Baseline, 13 weeks ]

9.  Secondary:   Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS)   [ Time Frame: Baseline, 13 weeks ]

10.  Secondary:   Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D)   [ Time Frame: Baseline, 13 weeks ]

11.  Secondary:   Mean Change From Baseline to Endpoint (13 Week) in 36-item Short-Form Health Survey   [ Time Frame: Baseline, 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
Due to a package labeling error, study drug was incorrectly administered to all patients in both treatment groups. This compromised the integrity of the entire study and rendered planned comparisons between duloxetine and placebo invalid.  


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: NCT00945945     History of Changes
Other Study ID Numbers: 13214, F1J-MC-HMGP
Study First Received: July 23, 2009
Results First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: United States: Food and Drug Administration