Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA

Neuropathic Pain Clinical Trial

— NI-PMS  

Official title:

Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843284
• Other study ID #: A0081139
• Secondary ID: ATLAS
• Status: Completed
• Start date: September 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Pregabalin
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Average Pain Scores	Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.	Baseline, Final Visit (Week 8 or discontinuation)
Primary	Pain Related Sleep Interference	Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep	Baseline, Final Visit (Week 8 or discontinuation)
Secondary	Anxiety and Depression Symptoms	The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.	Baseline, Final Visit (Week 8 or discontinuation)
Secondary	Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)	Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from "very much improved" to "very much worse".	Final Visit (Week 8 or discontinuation)
Secondary	Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)	Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse".	Final Visit (Week 8 or discontinuation)

External Links

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