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

Condition(s) targeted: Postherpetic Neuralgia

Intervention: pregabalin (Drug); pregabalin/PF-00489791 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: A Two Week Double-Blind Placebo-Controlled Crossover Study To Compare The Efficacy And Safety Of A Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Patients With Post-Herpetic Neuralgia

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint will be the 11-point Daily Pain Rating Scale. This will be collected daily by means of a telephone interactive voice recognition (IVR) system.

Secondary outcome:

Secondary efficacy endpoints will consist of the Patient Global Assessment of Change (PGIC), and the Neuropathic Pain Symptom Inventory (NPSI).

Safety endpoints will consist of adverse event reports, vital signs (blood pressure and heart rate) sitting and standing, 12-lead ECG, and laboratory safety tests.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Huntsville, Alabama 35801, United States; Recruiting

Pfizer Investigational Site, Tallassee, Alabama 36078, United States; Recruiting

Pfizer Investigational Site, Chandler, Arizona 85225, United States; Recruiting

Pfizer Investigational Site, Mesa, Arizona 85206, United States; Recruiting

Pfizer Investigational Site, Clovis, California 93611, United States; Recruiting

Pfizer Investigational Site, Fresno, California 93710, United States; Recruiting

Pfizer Investigational Site, Mission Viejo, California 92691, United States; Recruiting

Pfizer Investigational Site, Boca Raton, Florida 33486, United States; Recruiting

Pfizer Investigational Site, West Palm Beach, Florida 33407, United States; Recruiting

Pfizer Investigational Site, Delray Beach, Florida 33484, United States; Recruiting

Pfizer Investigational Site, Oak Brook, Illinois 60523, United States; Recruiting

Pfizer Investigational Site, Brockton, Massachusetts 02301, United States; Recruiting

Pfizer Investigational Site, Norwood, Massachusetts 02062, United States; Recruiting

Pfizer Investigational Site, Rochester, Minnesota 55905, United States; Not yet recruiting

Pfizer Investigational Site, Jackson, Mississippi 39202, United States; Recruiting

Pfizer Investigational Site, Hattiesburg, Mississippi 39401-7246, United States; Recruiting

Pfizer Investigational Site, Springfield, Missouri 65807, United States; Recruiting

Pfizer Investigational Site, North Platte, Nebraska 69101, United States; Active, not recruiting

Pfizer Investigational Site, Amherst, New York 14226, United States; Recruiting

Pfizer Investigational Site, Rochester, New York 14618, United States; Recruiting

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States; Recruiting

Pfizer Investigational Site, Lenoir, North Carolina 28645, United States; Recruiting

Pfizer Investigational Site, Bismarck, North Dakota 58501, United States; Active, not recruiting

Pfizer Investigational Site, Cincinnati, Ohio 45242, United States; Recruiting

Pfizer Investigational Site, Oklahoma City, Oklahoma 73112, United States; Recruiting

Pfizer Investigational Site, Johnstown, Pennsylvania 15904, United States; Recruiting

Pfizer Investigational Site, Cranberry Twp., Pennsylvania 16066, United States; Recruiting

Pfizer Investigational Site, Cranston, Rhode Island 02920, United States; Recruiting

Pfizer Investigational Site, Fort Worth, Texas 76104, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75231, United States; Not yet recruiting

Pfizer Investigational Site, Irving, Texas 75061, United States; Recruiting

Pfizer Investigational Site, Arlington, Texas 76012, United States; Recruiting

Pfizer Investigational Site, AUSTIN, Texas 78756, United States; Recruiting

Pfizer Investigational Site, Austin, Texas 78756, United States; Recruiting

Pfizer Investigational Site, Seattle, Washington 98104, United States; Not yet recruiting

Pfizer Investigational Site, Seattle, Washington 98122, United States; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: March 2008
Ending date: December 2008
Last updated: October 24, 2008