Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
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