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Описание
Краткое названиеPH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
Полное названиеA Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia
СпонсорPfizer
Industry
ИсточникPfizer
Под контролемUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Краткое описаниеThis 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.
СостояниеЗавершено
Дата началаMarch 2008
ФазаPhase 2
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion 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
ПолBoth
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеNeuralgia, Postherpetic
Применяемое лечение
DrugPH-797804
DrugPlacebo
Контакты и расположение
Dnipropetrovsk , 49616Pfizer Investigational Site
Donetsk , 83045Pfizer Investigational Site
Kharkiv , 61052Pfizer Investigational Site
Kharkiv , 61068Pfizer Investigational Site
Kharkiv , 61178Pfizer Investigational Site
Kyiv , 04050Pfizer Investigational Site
Odessa , 65025Pfizer Investigational Site
Simferopol , 95006Pfizer Investigational Site
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