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An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)

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ClinicalTrials.gov Identifier: NCT01621191
Recruitment Status : Completed
First Posted : June 18, 2012
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Fibromyalgia
Intervention: Drug: Duloxetine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who completed the 15-week treatment in the preceding study F1J-JE-HMGZ (HMGZ) (NCT01552057) were enrolled in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled participants who completed the 50-week treatment period were considered to have completed the study. After study completion or early discontinuation, participants completed a 2-week taper and were observed 1 week post-treatment for safety.

Reporting Groups
  Description
Duloxetine 60 mg

Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).

During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.


Participant Flow:   Overall Study
    Duloxetine 60 mg
STARTED   149 
Received at Least 1 Dose of Study Drug   149 
Had at Least 1 Post-Baseline Observation   148 
COMPLETED   124 
NOT COMPLETED   25 
Adverse Event                9 
Withdrawal by Subject                8 
Lack of Efficacy                6 
Lost to Follow-up                1 
Site Removed From Study                1 



  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.
Enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline observation.

Reporting Groups
  Description
Duloxetine 60 mg

Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).

During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily.


Baseline Measures
   Duloxetine 60 mg 
Overall Participants Analyzed 
[Units: Participants]
 148 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.3  (11.9) 
Gender 
[Units: Participants]
 
Female   121 
Male   27 
Race/Ethnicity, Customized 
[Units: Participants]
 
Japanese   148 
Region of Enrollment 
[Units: Participants]
 
Japan   148 


  Outcome Measures

1.  Primary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Baseline through 53 weeks ]

2.  Secondary:   Patient Global Impression-Improvement (PGI-I) at Endpoint   [ Time Frame: 50 weeks ]

3.  Secondary:   Clinical Global Impression-Improvement (CGI-I) at Endpoint   [ Time Frame: 50 weeks ]

4.  Secondary:   Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)   [ Time Frame: Baseline, 50 weeks ]

5.  Secondary:   Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form   [ Time Frame: Baseline, 50 weeks ]

6.  Secondary:   Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores   [ Time Frame: Baseline, 50 weeks ]

7.  Secondary:   Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)   [ Time Frame: Baseline, 50 weeks ]

8.  Secondary:   Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010   [ Time Frame: Baseline, 50 weeks ]


  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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01621191     History of Changes
Other Study ID Numbers: 14614
F1J-JE-HMHB ( Other Identifier: Eli Lilly and Company )
First Submitted: June 14, 2012
First Posted: June 18, 2012
Results First Submitted: January 27, 2015
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015