We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00892008
First Posted: May 1, 2009
Last Update Posted: January 12, 2010
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:
Pfizer
April 30, 2009
May 1, 2009
August 27, 2009
November 18, 2009
January 12, 2010
September 2006
August 2008   (Final data collection date for primary outcome measure)
  • Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) [ Time Frame: Baseline through Final Visit (Week 4) ]
  • Discontinuations Due to Adverse Events [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]
Safety and tolerability of pregabalin in the treatment of patients with wide variety of neuropathic pain syndromes based on incidence of adverse events. [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00892008 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Visual Analogue Scale (VAS) Score [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  • VAS Pain Score at Baseline (BL) and Second Visit [ Time Frame: Baseline, Second Visit (Week ≥ 2) ]
  • VAS Pain Score at Baseline and Final Visit [ Time Frame: Baseline, Final Visit (Week 4) ]
  • 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) ]
  • 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) ]
  • Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  • Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  • Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
  • Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ]
Efficacy of pregabalin in the treatment of patients with neuropathic pain based on Visual Analogue Scale [ Time Frame: 2 weeks ]
Not Provided
Not Provided
 
A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Male or female, 18 years and above diagnosed with neuropathic pain.
Neuropathic Pain
Drug: Pregabalin
Pregabalin 75-150 mg BID for at least 2 weeks.
Other Name: Lyrica
Open-Label
This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.
Intervention: Drug: Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2278
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, 18 years old and above diagnosed with neuropathic pain.

Exclusion Criteria:

  • Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00892008
A0081094
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010