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A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin (PAINS)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00892008
First received: April 30, 2009
Last updated: January 8, 2010
Last verified: January 2010
Results First Received: August 27, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Neuropathic Pain
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
Phase 4 nationwide post-marketing surveillance study conducted between Sep 2006 and Aug 2008.

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 75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     2278  
COMPLETED     1713  
NOT COMPLETED     565  
Death                 5  
Lack of Efficacy                 3  
Lost to Follow-up                 142  
unspecified                 378  
Adverse Event                 37  



  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 75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  2278  
Age, Customized  
[units: participants]
 
18-44 years     582  
45-64 years     1054  
≥ 65 years     451  
unspecified     191  
Gender, Customized  
[units: participants]
 
female     1324  
male     932  
unspecified     22  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)   [ Time Frame: Baseline through Final Visit (Week 4) ]

2.  Primary:   Discontinuations Due to Adverse Events   [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]

3.  Secondary:   Change From Baseline in Visual Analogue Scale (VAS) Score   [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]

4.  Secondary:   VAS Pain Score at Baseline (BL) and Second Visit   [ Time Frame: Baseline, Second Visit (Week ≥ 2) ]

5.  Secondary:   VAS Pain Score at Baseline and Final Visit   [ Time Frame: Baseline, Final Visit (Week 4) ]

6.  Secondary:   Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits   [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]

7.  Secondary:   Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits   [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]

8.  Secondary:   Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit   [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]

9.  Secondary:   Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit   [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]

10.  Secondary:   Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist   [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]

11.  Secondary:   Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit   [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]


  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
No text entered.


  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


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00892008     History of Changes
Other Study ID Numbers: A0081094
Study First Received: April 30, 2009
Results First Received: August 27, 2009
Last Updated: January 8, 2010
Health Authority: Philippines: Bureau of Food and Drugs