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

NCT ID: NCT00631943

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-03-31

Brief Summary

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

Detailed Description

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Conditions

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Neuralgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pregabalin (Lyrica)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka / India, India

Site Status

Pfizer Investigational Site

Mumbai, Maharashtra, India

Site Status

Pfizer Investigational Site

Maharashtra, Mumbai, India

Site Status

Pfizer Investigational Site

Chennai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Chennai, Tamil Nadu, India

Site Status

Countries

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India

Related Links

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Other Identifiers

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A0081068

Identifier Type: -

Identifier Source: org_study_id

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