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

April 30, 2009
January 8, 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) ] [ Designated as safety issue: Yes ]
  • Discontinuations Due to Adverse Events [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: No ]
  • VAS Pain Score at Baseline (BL) and Second Visit [ Time Frame: Baseline, Second Visit (Week ≥ 2) ] [ Designated as safety issue: No ]
  • VAS Pain Score at Baseline and Final Visit [ Time Frame: Baseline, Final Visit (Week 4) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
  • Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
  • Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
  • Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
Efficacy of pregabalin in the treatment of patients with neuropathic pain based on Visual Analogue Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00892008
A0081094
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP