A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin (PAINS)

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00892008

First received: April 30, 2009

Last updated: January 8, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2009

Last Updated Date

January 8, 2010

Start Date ^ICMJE

September 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4) [ Time Frame: Baseline through Final Visit (Week 4) ] [ Designated as safety issue: Yes ]
Discontinuations Due to Adverse Events [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00892008 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change From Baseline in Visual Analogue Scale (VAS) Score [ Time Frame: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
VAS Pain Score at Baseline (BL) and Second Visit [ Time Frame: Baseline, Second Visit (Week ≥ 2) ] [ Designated as safety issue: No ]
VAS Pain Score at Baseline and Final Visit [ Time Frame: Baseline, Final Visit (Week 4) ] [ Designated as safety issue: No ]
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit [ Time Frame: Second Visit (Week ≥ 2), Final Visit (Week 4) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin

Official Title ^ICMJE

Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin

Brief Summary

This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Neuropathic Pain

Intervention ^ICMJE

Drug: Pregabalin

Pregabalin 75-150 mg BID for at least 2 weeks.

Other Name: Lyrica

Study Group/Cohort (s)

Open-Label

This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.

Intervention: Drug: Pregabalin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2278

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00892008

Other Study ID Numbers ^ICMJE

A0081094

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2010

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

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