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Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

NCT ID: NCT00219544

Last Updated: 2021-01-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-02-29

Brief Summary

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This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).

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Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Pregabalin (Lyrica)

Intervention Type DRUG

pregabalin 150mg/day (75mg BID)

2

Group Type EXPERIMENTAL

Pregabalin (Lyrica)

Intervention Type DRUG

pregabalin 300 mg/day (150mg BID)

3

Group Type EXPERIMENTAL

Pregabalin (Lyrica)

Intervention Type DRUG

pregabalin 600/day (300mg BID)

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Pregabalin (Lyrica)

pregabalin 150mg/day (75mg BID)

Intervention Type DRUG

Pregabalin (Lyrica)

pregabalin 300 mg/day (150mg BID)

Intervention Type DRUG

Pregabalin (Lyrica)

pregabalin 600/day (300mg BID)

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
* At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.

Exclusion Criteria

* Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.
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

Calgary, Alberta, Canada

Site Status

Pfizer Investigational Site

Calgary, Alberta, Canada

Site Status

Pfizer Investigational Site

Calgary, Alberta, Canada

Site Status

Pfizer Investigational Site

Edmonton, Alberta, Canada

Site Status

Pfizer Investigational Site

Edmonton, Alberta, Canada

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Pfizer Investigational Site

Red Deer, Alberta, Canada

Site Status

Pfizer Investigational Site

Kelowna, British Columbia, Canada

Site Status

Pfizer Investigational Site

Vancouver, British Columbia, Canada

Site Status

Pfizer Investigational Site

Vancouver, British Columbia, Canada

Site Status

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

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Pfizer Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

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Pfizer Investigational Site

Kingston, Ontario, Canada

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Pfizer Investigational Site

London, Ontario, Canada

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Pfizer Investigational Site

Port Hope, Ontario, Canada

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Pfizer Investigational Site

Toronto, Ontario, Canada

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Pfizer Investigational Site

Charlottetown, Prince Edward Island, Canada

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Pfizer Investigational Site

Granby, Quebec, Canada

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Pfizer Investigational Site

Laval, Quebec, Canada

Site Status

Pfizer Investigational Site

Laval, Quebec, Canada

Site Status

Pfizer Investigational Site

Lévis, Quebec, Canada

Site Status

Pfizer Investigational Site

Mirabel, Quebec, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

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Pfizer Investigational Site

Montreal, Quebec, Canada

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Pfizer Investigational Site

Sherbrooke, Quebec, Canada

Site Status

Pfizer Investigational Site

Sherbrook, Quebec, Canada

Site Status

Pfizer Investigational Site

Ste-Foy, Quebec, Canada

Site Status

Pfizer Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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A0081084

Identifier Type: -

Identifier Source: org_study_id

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