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Pregabalin In Adolescent Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020526
First received: November 23, 2009
Last updated: May 24, 2016
Last verified: May 2016
Results First Received: May 24, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   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
A total of 63 participants were screened and enrolled at 19 study centers in this open-label extension study to the parent double-blind randomized fibromyalgia study A0081180.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pregabalin Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     63  
COMPLETED     49  
NOT COMPLETED     14  
Withdrawal by Subject                 5  
Other reasons                 3  
Insufficient clinical response                 3  
Lost to Follow-up                 1  
Adverse Event                 2  



  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
Pregabalin Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  63  
Age  
[units: Years]
Mean (Standard Deviation)
  14.8  (1.4)  
Gender  
[units: Participants]
 
Female     53  
Male     10  



  Outcome Measures

1.  Primary:   Change From Baseline in Pain Numeric Rating Scale by Week   [ Time Frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit. ]


  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.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01020526     History of Changes
Other Study ID Numbers: A0081231
2010-020300-29 ( EudraCT Number )
Study First Received: November 23, 2009
Results First Received: May 24, 2016
Last Updated: May 24, 2016
Health Authority: United States: Food and Drug Administration