A FOUR WEEK, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY OF PH-797804 IN THE TREATMENT OF POST-HERPETIC NEURALGIA
- Conditions
- Post-herpetic neuralgia (PHN)MedDRA version: 9.1Level: LLTClassification code 10036376Term: Post herpetic neuralgia
- Registration Number
- EUCTR2007-005781-12-SE
- Lead Sponsor
- Pfizer Limited, Ramsgate Road, Sandwich, Kent UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Male or female, at least 18 years of age
2. Females must be of non-childbearing potential. Females of non-child-bearing potential will be defined as:
• Females with a documented hysterectomy and/or bilateral oophrectomy, or
• Females have been amenorrheic for at least 2 years and have a serum FSH level >30 IU/L in the absence of hormone replacement therapy
3. 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.
4. Patients at screening visit (V1) must have a score =40 mm on the Pain Visual Analog Score (VAS).
5. Patients must be able to understand and cooperate with trial procedures, and have signed a written informed consent prior to entering the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for post-herpetic neuralgia
2. Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
3. History of chronic hepatitis B or C within the past 3 months, or HIV infection
4. Patients who have a history of alcohol or illicit drug abuse in the past 2 years.
5. History of cancer (other than cutaneous basal cell) in the previous 5 years.
6. 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).
7. Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Deriviative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG). Refer to Section 7.2.4 for additional clarification.
8. A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold test™) where used. Refer to Section 7.2.4 for additional clarification
9. History within the previous 6 months of:
• An epileptic seizure.
• Poorly controlled Type 1 or Type 2 diabetes.
• Acute hepatitis of any aetiology.
10. Presenting with:
• Any condition possibly affecting oral drug absorption (e.g. gastrectomy or clinically significant diabetic gastroenteropathy);
• Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0;
• Any clinically significant active infection
• Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV;
11. A major surgical operation within 1 month of screening.
12. ECG abnormalities at screening or randomization, including those listed below. The investigator will decide whether ECG abnormalities other than those listed are clinically significant and should exclude the subject from enrolment if abnormality is considered to be clinically significant:
• Subjects with pre-randomization evidence of QTc prolongation at screening (V1) or at V2 (defined as >450 ms) are not eligible for randomization. This assessment is based on a confirmed mean of the triplicate ECG recordings and is made by the investigator at the time of ECG collection.
• Predominant heart rhythm other than normal sinus rhythm e.g. atrial fibrillation, atrial flutter, supraventricular tachycardia.
• Atrioventricular (AV) block greater than first degree.
• Resting heart rate >100 or <40 bpm.
• Evidence of previous myocardial infarction in the absence of clinical history consistent with these findings.
• Evidence of acute ischaemia.
13. Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments:
• Hgb <10 g/dL, Hct <32%;
• Absolute WBC count <3.0 x 109/L (<3000/mm3)
• Neutrophil count < 1.2 x 109/L (<1200/mm3)
• Platelet count <100 x 109/L (<100,000/mm3)
• AST or ALT >1.2 x ULN
• Total bilirubin >1.2 x ULN
• Alkaline phosphatase >1.2 x ULN
• Albumin <3.5 g/dL or 35 g/L due to known liver disease
• Serum creatinine >ULN
14. Use of any of the prohibited concomitant medications within the time frame prior to the sta
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the efficacy of PH-797804 in patients with post-herpetic neuralgia.<br>• To evaluate the safety and tolerability of PH-797804 in patients with post-herpetic neuralgia.<br>• To collect blood samples for pharmacokinetic analysis of PH-797804 in patients with post-herpetic neuralgia.;Secondary Objective: Not Applicable;Primary end point(s): Daily Pain Rating Scale (11-point Numeric Rating Scale)
- Secondary Outcome Measures
Name Time Method