Adolescent Fibromyalgia Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020474
First received: November 23, 2009
Last updated: June 22, 2015
Last verified: June 2015
Results First Received: May 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: placebo
Drug: pregabalin (Lyrica)

  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 147 participants were screened, 107 participants were randomized to treatment. The 107 randomized participants were recruited in 4 countries at 23 study centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study consisted of 4 phases, screening (1 Week), dose optimization (3 Weeks), fixed dose (12 Weeks) and follow-up (1 Week).

Reporting Groups
  Description
Pregabalin Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.

Participant Flow:   Overall Study
    Pregabalin     Placebo  
STARTED     54     53  
COMPLETED     44     36  
NOT COMPLETED     10     17  
Adverse Event                 4                 4  
Protocol Violation                 0                 2  
Withdrawal by Subject                 5                 7  
Other Reasons                 1                 1  
Insufficient Clinical Response                 0                 3  



  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 Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
Placebo Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
Total Total of all reporting groups

Baseline Measures
    Pregabalin     Placebo     Total  
Number of Participants  
[units: participants]
  54     53     107  
Age  
[units: years]
Mean (Standard Deviation)
  14.6  (1.2)     14.7  (1.2)     14.7  (1.2)  
Gender  
[units: participants]
     
Female     48     44     92  
Male     6     9     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 15 in Mean Pain Diary Score   [ Time Frame: Week 15 ]

2.  Secondary:   Change From Baseline to Week 15 in Mean Sleep Quality Diary Score   [ Time Frame: Week 15 ]

3.  Secondary:   Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)   [ Time Frame: Baseline to Week 15 ]

4.  Secondary:   Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)   [ Time Frame: Baseline to Week 15 ]

5.  Secondary:   Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)   [ Time Frame: Week 15 ]

6.  Secondary:   Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15   [ Time Frame: Week 15 ]

7.  Secondary:   Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15   [ Time Frame: Week 15 ]

8.  Secondary:   Proportion of Patient Global Impression Change (PGIC) at Week 15   [ Time Frame: Week 15 ]


  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: NCT01020474     History of Changes
Other Study ID Numbers: A0081180
2010-019521-34 ( EudraCT Number )
Study First Received: November 23, 2009
Results First Received: May 26, 2015
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration