Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00843284
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : April 16, 2009
Last Update Posted : October 28, 2009
Sponsor:
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment
Neuropathic Pain Drug: Pregabalin

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 691 participants
Time Perspective: Prospective
Official Title: Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)
Study Start Date : September 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Group/Cohort Intervention/treatment
Patients with neuropathic pain Drug: Pregabalin
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks




Primary Outcome Measures :
  1. Daily Average Pain Scores [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ]
    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.

  2. Pain Related Sleep Interference [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ]
    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


Secondary Outcome Measures :
  1. Anxiety and Depression Symptoms [ Time Frame: Baseline, Final Visit (Week 8 or discontinuation) ]
    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.

  2. Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) [ Time Frame: 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".

  3. Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) [ Time Frame: 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".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with neuropathic pain
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843284


Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00843284    
Other Study ID Numbers: A0081139
ATLAS
First Posted: February 13, 2009    Key Record Dates
Results First Posted: April 16, 2009
Last Update Posted: October 28, 2009
Last Verified: October 2009
Keywords provided by Pfizer:
neuropathic, pain, pregabalin, Lyrica
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs