Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

Phase 2TerminatedNCT00159640

Pfizer315 enrolled

Overview

The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

315

Conditions

Pain

Interventions

PD-217,014DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have pain present for more than 3 months after the healing of shingles skin rash. * Patients at screening must have a score \>=40 mm on the pain visual analogue scale. Exclusion Criteria: * Patients with poor renal function. * Patients with other severe pain, that may impair the self-assessment of the pain due to shingles. * Patients with abnormal electrocardiogram.

Locations (32)

Outcomes

Primary Outcomes

To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.

Secondary Outcomes

- Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Warrawong, New South Wales, Australia

Pfizer Investigational Site

Westmead, New South Wales, Australia

Pfizer Investigational Site

Kippa-Ring, Queensland, Australia

Pfizer Investigational Site

Maroochydore, Queensland, Australia

Pfizer Investigational Site

Bedford Park, South Australia, Australia

Pfizer Investigational Site

Perth, Western Australia, Australia

Pfizer Investigational Site

Woodville, Australia

Pfizer Investigational Site

Kelowna, British Columbia, Canada

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Pfizer Investigational Site

Toronto, Ontario, Canada

...and 22 more locations