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Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA (NI-PMS)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00843284
First received: February 12, 2009
Last updated: October 21, 2009
Last verified: October 2009
History of Changes

February 12, 2009
October 21, 2009
September 2006
March 2008   (final data collection date for primary outcome measure)
  • Daily Average Pain Scores [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ] [ Designated as safety issue: No ]
  • Pain Related Sleep Interference [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ] [ Designated as safety issue: No ]
  • Impact of pregabalin on pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Impact of pregabalin on quality of sleep [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Impact of pregabalin on general wellbeing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00843284 on ClinicalTrials.gov Archive Site
  • Anxiety and Depression Symptoms [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ] [ Designated as safety issue: No ]
  • Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) [ Time Frame: Final Visit (Week 8 or discontinuation) ] [ Designated as safety issue: No ]
  • Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) [ Time Frame: Final Visit (Week 8 or discontinuation) ] [ Designated as safety issue: No ]
  • Presence of anxiety and depression symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Dose and dosage scheme used [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Co-administration of other drugs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in the severity of the condition as rated using global assessments by both the subject and the physician [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Tolerability of pregabalin and reported adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA
Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)

A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.

A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with neuropathic pain
Neuropathic Pain
Drug: Pregabalin
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks
Patients with neuropathic pain
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
691
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.

Exclusion Criteria:

  • The patients were excluded according to the current Summary of Product Characteristics.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00843284
A0081139, ATLAS
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

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