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Lyrica (Pregabalin) Korean Post Marketing Surveillance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01220180
First received: October 7, 2010
Last updated: November 3, 2011
Last verified: November 2011
Results First Received: November 3, 2011  
Study Type: Observational
Study Design: Observational Model: Ecologic or Community;   Time Perspective: Prospective
Conditions: Epilepsy
Neuropathic Pain
Fibromyalgia
Post-market Surveillance
Intervention: 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
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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 Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     4175  
Treated     4174  
COMPLETED     3968  
NOT COMPLETED     207  
Lost to Follow-up                 76  
Unspecified                 72  
Adverse Event                 35  
Lack of Efficacy                 22  
Death                 1  
Randomized but not treated                 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.
No text entered.

Reporting Groups
  Description
Pregabalin: Epilepsy Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
Pregabalin: Neuropathic Pain Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
Pregabalin: Fibromyalgia Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
Total Total of all reporting groups

Baseline Measures
    Pregabalin: Epilepsy     Pregabalin: Neuropathic Pain     Pregabalin: Fibromyalgia     Total  
Number of Participants  
[units: participants]
  787     3266     121     4174  
Age, Customized  
[units: Participants]
       
Less than 20 years     37     2     0     39  
20 to 29 years     192     26     3     221  
30 to 39 years     158     105     8     271  
40 to 49 years     146     409     30     585  
50 to 59 years     119     840     36     995  
60 to 69 years     89     1094     28     1211  
Greater than and equal to 70 years     46     790     16     852  
Gender  
[units: Participants]
       
Female     364     1689     83     2136  
Male     423     1577     38     2038  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population   [ Time Frame: Baseline through Week 12 ]

2.  Primary:   Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population   [ Time Frame: Baseline through Week 12 ]

3.  Primary:   Percentage of Participants With Improvement in Seizure Frequency in ITT Population   [ Time Frame: Baseline through Week 12 ]

4.  Primary:   Percentage of Participants With Improvement in Seizure Frequency in PP Population   [ Time Frame: Baseline through Week 12 ]

5.  Primary:   Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6   [ Time Frame: Baseline and Week 6 ]

6.  Primary:   Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6   [ Time Frame: Baseline and Week 6 ]

7.  Primary:   Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6   [ Time Frame: Baseline and Week 6 ]

8.  Primary:   Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6   [ Time Frame: Baseline and Week 6 ]

9.  Secondary:   Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6   [ Time Frame: Baseline and Week 6 ]

10.  Secondary:   Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6   [ Time Frame: Baseline and Week 6 ]

11.  Secondary:   Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6   [ Time Frame: Baseline and Week 6 ]

12.  Secondary:   Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6   [ Time Frame: Baseline and Week 6 ]

13.  Secondary:   Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population   [ Time Frame: Week 6 ]

14.  Secondary:   Number of Participants With CGIC Scale for NeP in PP Population   [ Time Frame: Week 6 ]

15.  Secondary:   Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population   [ Time Frame: Week 6 ]

16.  Secondary:   Number of Participants With PGIC Scale for NeP in PP Population   [ Time Frame: Week 6 ]

17.  Secondary:   Number of Participants With CGIC Scale for Fibromyalgia in ITT Population   [ Time Frame: Week 6 ]

18.  Secondary:   Number of Participants With CGIC Scale for Fibromyalgia in PP Population   [ Time Frame: Week 6 ]

19.  Secondary:   Number of Participants With PGIC Scale for Fibromyalgia in ITT Population   [ Time Frame: Week 6 ]

20.  Secondary:   Number of Participants With PGIC Scale for Fibromyalgia in PP Population   [ Time Frame: Week 6 ]


  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
It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.


  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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01220180     History of Changes
Other Study ID Numbers: A0081138
Study First Received: October 7, 2010
Results First Received: November 3, 2011
Last Updated: November 3, 2011
Health Authority: Korea: Korean Food and Drug Administration