A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

NCT ID: NCT00599638

Last Updated: 2021-08-05

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

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-09

Study Completion Date

2008-12-23

Brief Summary

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Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.

Detailed Description

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Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

pregabalin

Intervention Type DRUG

75mg bid titrating to 150mg bid on day 4

2

Group Type EXPERIMENTAL

pregabalin/PF-00489791

Intervention Type DRUG

Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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pregabalin

75mg bid titrating to 150mg bid on day 4

Intervention Type DRUG

pregabalin/PF-00489791

Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female of non-childbearing potential
* Pain present for more than 3 months after healing of herpes zoster skin rash
* VAS score of \>=40mm at screening and baseline visits

Exclusion Criteria

* Patients with pain conditions which might impair the assessment of postherpetic neuralgia
* Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
* History or diagnosis of DSM IV major depressive disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

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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North Alabama RadioPharmacy

Huntsville, Alabama, United States

Site Status

Tennessee Valley Pain Consultants

Huntsville, Alabama, United States

Site Status

River Region Research, LLC

Tallassee, Alabama, United States

Site Status

Radiant Research

Chandler, Arizona, United States

Site Status

Novara Clinical Research

Mesa, Arizona, United States

Site Status

Community Medical Providers

Clovis, California, United States

Site Status

Sierra Medical Research (Administrative only site)

Fresno, California, United States

Site Status

Prime-Care Clinical Research

Mission Viejo, California, United States

Site Status

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Site Status

Bradenton Research Center

Bradenton, Florida, United States

Site Status

Arthritis Associates of South Florida

Delray Beach, Florida, United States

Site Status

Delray Research Associates

Delray Beach, Florida, United States

Site Status

Office of Laszlo J Mate, M.D.

West Palm Beach, Florida, United States

Site Status

American Medical Research, Inc.

Oak Brook, Illinois, United States

Site Status

Beacon Clinical Research

Brockton, Massachusetts, United States

Site Status

ICPS Group

Norwood, Massachusetts, United States

Site Status

Neurological Research Center at Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Site Status

CRC of Jackson

Jackson, Mississippi, United States

Site Status

Physician's Surgery Center

Jackson, Mississippi, United States

Site Status

Clinvest

Springfield, Missouri, United States

Site Status

Centennial Park Medical Building

North Platte, Nebraska, United States

Site Status

Neurology Associates of Great Plains

North Platte, Nebraska, United States

Site Status

Finger Lakes Clinical Research

Rochester, New York, United States

Site Status

North State Clinical Research, PLLC

Lenoir, North Carolina, United States

Site Status

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Legacy Pharma Research

Bismarck, North Dakota, United States

Site Status

Patient Priority Clinical Sites, LLC

Cincinnati, Ohio, United States

Site Status

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Mark A. Fisher, MD-Private Practice

Oklahoma City, Oklahoma, United States

Site Status

Absolute Primary Care, P.C.

Cranberry Twp., Pennsylvania, United States

Site Status

John P. Murtha Neuroscience and Pain Institute

Johnstown, Pennsylvania, United States

Site Status

Memorial Medical Center

Johnstown, Pennsylvania, United States

Site Status

New England Center for Clinical Research

Cranston, Rhode Island, United States

Site Status

Medical Clinic of North Texas

Arlington, Texas, United States

Site Status

FutureSearch Trials of Neurology

Austin, Texas, United States

Site Status

Futuresearch Trials

Austin, Texas, United States

Site Status

Pinnacle Pain Medicine

Dallas, Texas, United States

Site Status

The Medical Group Of Texas

Fort Worth, Texas, United States

Site Status

Medical and Surgical Clinic of Irving

Irving, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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B0261002

Identifier Type: -

Identifier Source: org_study_id

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