This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00346034
First received: June 28, 2006
Last updated: March 30, 2009
Last verified: March 2009
Results First Received: February 12, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fibromyalgia
Intervention: Drug: Pregabalin

  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
The study was planned to include all eligible subjects continuing from the preceding double-blind study A0081100 NCT00333866 (Subjects had to be at least 18 years old and have met the American College of Rheumatology criteria for fibromyalgia).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following the termination visit in study A0081100, subjects had an option of starting pregabalin under open-label conditions the day after the termination visit.

Reporting Groups
  Description
Pregabalin Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     357  
COMPLETED     300  
NOT COMPLETED     57  
Adverse Event                 34  
Lack of Efficacy                 8  
Withdrawal by Subject                 13  
Patient Stopped Taking Study Drug                 1  
Not Willing to Follow Dosing Regimen                 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
Pregabalin Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  357  
Age  
[units: years]
Mean ± Standard Deviation
  48.3  ± 11.1  
Gender  
[units: participants]
 
Female     322  
Male     35  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score   [ Time Frame: Week 4 ]

2.  Primary:   Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score   [ Time Frame: Week 12 (end of treatment) ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00346034     History of Changes
Other Study ID Numbers: A0081101
Study First Received: June 28, 2006
Results First Received: February 12, 2009
Last Updated: March 30, 2009
Health Authority: United States: Food and Drug Administration