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Pregabalin In Adolescent Patients With Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020526
First Posted: November 25, 2009
Last Update Posted: July 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: May 24, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Masking: None (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 
Overall Participants Analyzed 
[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


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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01020526     History of Changes
Other Study ID Numbers: A0081231
2010-020300-29 ( EudraCT Number )
First Submitted: November 23, 2009
First Posted: November 25, 2009
Results First Submitted: May 24, 2016
Results First Posted: July 1, 2016
Last Update Posted: July 1, 2016