A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00631943

First received: March 3, 2008

Last updated: April 22, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2008

Last Updated Date

April 22, 2011

Start Date ^ICMJE

November 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in weekly mean pain scores [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00631943 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Adverse events and laboratory value changes [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: Yes ]
Change from baseline in weekly mean sleep interference score [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in Patient Global Impression of Change (PGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in Clinical Global Impression of Change (CGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Adverse events and laboratory value changes [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: Yes ]
Change from baseline in weekly mean sleep interference score [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in Patient Global Impression of Change (PGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in Clinical Global Impression of Change (CGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
Change from baseline in pain intereference scores on the Brief Pain Inventory (BPI ) Short-Form [ Time Frame: End of treatment ] [ 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 Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain

Official Title ^ICMJE

An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neuralgia

Intervention ^ICMJE

Drug: Pregabalin (Lyrica)

Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days.

Study Arm (s)

Experimental: 1

Intervention: Drug: Pregabalin (Lyrica)

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

112

Completion Date

March 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion criteria:

Peripheral neuropathic pain
Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline

Exclusion criteria:

(none)

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

India

Administrative Information

NCT Number ^ICMJE

NCT00631943

Other Study ID Numbers ^ICMJE

A0081068

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

April 2011

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

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