Status:
COMPLETED
PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
Lead Sponsor:
Pfizer
Conditions:
Neuralgia, Postherpetic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00614705
Start Date
April 1 2008
End Date
December 1 2008
Last Update
May 16 2011
Active Locations (25)
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1
Pfizer Investigational Site
Viña del Mar, Región de Valparaíso, Chile, 2520997
2
Pfizer Investigational Site
Moscow, Russia, 123098
3
Pfizer Investigational Site
Saint Petersburg, Russia, 194175
4
Pfizer Investigational Site
Saint Petersburg, Russia, 194354