A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00892008

Purpose

This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study.

Condition	Intervention	Phase
Neuropathic Pain	Drug: Pregabalin	Phase IV

Drug Information available for: Pregabalin

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (Pains): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	3000
Study Start Date:	September 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
open label This is open label with only one group	Drug: Pregabalin Pregabalin 75-150 mg BID for at least 2 weeks.

Detailed Description:

This is open label and patient was enrolled once decision to to prescribe the medication has been made by the Investigator.

Eligibility

Study Population

Male or female, 18 years and above diagnosed with neuropathic pain.

Criteria

Inclusion Criteria:

Exclusion Criteria:

Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892008

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0081094
Study First Received:	April 30, 2009
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00892008 History of Changes
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:

pregabalin, neuropathic pain, safety

Study placed in the following topic categories:

Pregabalin
Pain
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Pregabalin
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009