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
  Purpose

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 Intervention Phase
Neuropathic Pain
Drug: Pregabalin
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 691
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with neuropathic pain Drug: Pregabalin
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843284

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00843284     History of Changes
Other Study ID Numbers: A0081139, ATLAS
Study First Received: February 12, 2009
Results First Received: March 11, 2009
Last Updated: October 21, 2009
Health Authority: Greece: Ethics Committee

Keywords provided by Pfizer:
neuropathic, pain, pregabalin, Lyrica

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014