PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
Status and phase
Completed
Phase 2
Conditions
Neuralgia, Postherpetic
Treatments
Drug: Placebo
Drug: PH-797804
Details and patient eligibility
About
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.
Enrollment
80 patients
Sex
All
Ages
18+ years old
Volunteers
No 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
80 participants in 2 patient groups, including a placebo group
1
Experimental group
Treatment:
Drug: PH-797804
2
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
25
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Data sourced from clinicaltrials.gov
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