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A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT01855919
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Back Pain Lower Back Chronic
Interventions: Drug: Duloxetine
Drug: Placebo

  Participant Flow

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
The participant flow includes information on participants who completed the study. 2 participants who were assigned to receive placebo received duloxetine instead. These participants were treated as placebo in efficacy analysis and as duloxetine in safety analysis. In the participant flow, these participants are included under placebo.

Reporting Groups
  Description
Duloxetine Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
Placebo Placebo administered in capsule form orally once every day for 15 weeks.

Participant Flow:   Overall Study
    Duloxetine   Placebo
STARTED   232   226 
Received at Least 1 Dose of Study Drug   232   226 
COMPLETED   209   200 
NOT COMPLETED   23   26 
Adverse Event                16                8 
Lack of Efficacy                1                3 
Withdrawal by Subject                4                10 
Entry Criteria Not Met                1                1 
Protocol Violation                1                4 



  Baseline Characteristics

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.
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose Brief Pain Inventory (BPI) pain severity (average pain) scores.

Reporting Groups
  Description
Duloxetine Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
Placebo Placebo administered in capsule form orally once every day for 15 weeks.
Total Total of all reporting groups

Baseline Measures
   Duloxetine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 230   226   456 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (13.2)   57.8  (13.7)   58.9  (13.4) 
Gender 
[Units: Participants]
     
Female   115   122   237 
Male   115   104   219 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   230   226   456 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   230   226   456 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   0   0   0 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Japan   230   226   456 


  Outcome Measures

1.  Primary:   Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item   [ Time Frame: Baseline, Week 14 ]

2.  Secondary:   Patient Global Impression of Improvement (PGI-I) at Week 14   [ Time Frame: Week 14 ]

3.  Secondary:   Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14   [ Time Frame: Baseline, Week 14 ]

4.  Secondary:   Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14   [ Time Frame: Baseline, Week 14 ]

5.  Secondary:   Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14   [ Time Frame: Baseline, Week 14 ]

6.  Secondary:   Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14   [ Time Frame: Baseline, Week 14 ]

7.  Secondary:   Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score   [ Time Frame: Baseline through Week 14 ]

8.  Secondary:   Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14   [ Time Frame: Baseline, Week 14 ]

9.  Secondary:   Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14   [ Time Frame: Baseline, Week 14 ]

10.  Secondary:   Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14   [ Time Frame: Baseline, Week 14 ]

11.  Secondary:   Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14   [ Time Frame: Baseline, Week 14 ]

12.  Secondary:   Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14   [ Time Frame: Baseline, Week 14 ]

13.  Secondary:   Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]   [ Time Frame: Baseline through Week 14 ]

14.  Secondary:   Percentage of Participants With Fall Events in Fall Questionnaire   [ Time Frame: Baseline through Week 14 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01855919     History of Changes
Other Study ID Numbers: 14376
F1J-JE-HMGY ( Other Identifier: Eli Lilly and Company )
First Submitted: May 14, 2013
First Posted: May 17, 2013
Results First Submitted: June 26, 2015
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015