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COMPLETEDPHASE2

PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

A Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia

NCT00614705•Pfizer

View on ClinicalTrials.gov

Summary

This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, at least 18 years of age
•Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
•Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).

Exclusion Criteria

•Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
•History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
•Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
•A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
•Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
•ECG abnormalities at screening or randomization
•Evidence of organ dysfunction or hematopoietic disorder

Locations (25)

Pfizer Investigational Site

Viña del Mar, Región de Valparaíso, Chile

Pfizer Investigational Site

Moscow, Russia

Pfizer Investigational Site

Saint Petersburg, Russia

Pfizer Investigational Site

Saint Petersburg, Russia

Pfizer Investigational Site

Yaroslavl, Russia

Pfizer Investigational Site

Cadiz, Cadiz, Spain

Pfizer Investigational Site

Madrid, Madrid, Spain

Pfizer Investigational Site

Ourense, Ourense, Spain

Pfizer Investigational Site

Seville, Sevilla, Spain

Pfizer Investigational Site

Valencia, Valencia, Spain

Key Dates

Start Date

April 1, 2008

Primary Completion Date

November 1, 2008

Completion Date

December 1, 2008

Last Updated

May 16, 2011

Enrollment

ACTUAL participants

Conditions

Neuralgia, Postherpetic

Interventions

PH-797804

DRUG

Placebo

DRUG

A Research Study to Evaluate the Safety and Effectiveness of MK0686 for the Treatment of Postherpetic Neuralgia (Also Known as PHN or Post Shingles Pain) (0686-005)

NCT00282763

Neuralgia, Postherpetic

View study

TERMINATEDPHASE2

Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)

NCT00245544

Neuralgia, Postherpetic

View study

COMPLETEDPHASE1

Neuropathic Pain Syndrome Patient Study (MK-0000-072)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

Inclusion Criteria

Exclusion Criteria

A Research Study to Evaluate the Safety and Effectiveness of MK0686 for the Treatment of Postherpetic Neuralgia (Also Known as PHN or Post Shingles Pain) (0686-005)

Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)

Neuropathic Pain Syndrome Patient Study (MK-0000-072)

A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)

A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment

Effect of Opioids in Neuropathic Pain in Postherpetic Patients