A FOUR WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP, PHASE 2A STUDY OF VARENICLINE TARTRATE (CP-526,555) IN THE TREATMENT OF POST-HERPETIC NEURALGIA
- Conditions
- POST-HERPETIC NEURALGIAMedDRA version: 9.1Level: LLTClassification code 10036376Term: Post herpetic neuralgia
- Registration Number
- EUCTR2008-002208-24-CZ
- Lead Sponsor
- Pfizer Inc., 235 East 42nd Street,New York,NY 10017
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 74
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.
Females – Non-childbearing Potential:
Female subjects of non-childbearing potential must meet at least one of the following
criteria:
• Post menopausal females
• Females who are surgically sterile, defined as having had a documented hysterectomy
and/or bilateral oophorectomy
Females – Childbearing Potential:
• Defined as using adequate contraception consisting of 2 forms of birth control, one of
which must be a barrier method, is not pregnant, lactating, and is not breastfeeding.
Females of childbearing potential must have a negative serum pregnancy test at
Baseline (V1).
Male Contraception Guidelines:
• Male patients must agree that female spouses/partners will use contraception as
defined above or be of non-childbearing potential (post-menopausal or surgically
sterile);
2. 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;
3. Patients must have a score of greater than or equal to (=) 4 for pain from PHN on the 11- point NRS pain scale administered in the clinic at the Baseline (V1) visit. Note that the
baseline phase of the study will only begin after the required 2-week minimum washout
period from all prohibited concomitant medications;
4. Patients must have an average daily pain score greater than or equal to (=) 4 and completed at least 4 daily pain diaries over the 7 days of the Baseline phase of the study (assessed at V2);
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 are tobacco users including cigarette smokers and users of non-cigarette tobacco products within 6 months prior to Baseline. Use of smoking cessation products including prescription medications such as buproprion and varenicline within 6 months prior to Baseline;
2.Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN;
3.Severe pain, which may impair the self-assessment of the pain due to
PHN;
4.Skin conditions in the affected dermatome that could alter sensation, other than PHN;
5.Chronic hepatitis B or C, acute hepatitis B or C within the past 3 months;
6.History of HIV infection;
7.A history of alcohol or illicit drug abuse or dependency in the past 2 years. In addition, patients who fail a urine toxicology screen for illegal drugs;
8.Active cancer, including suspected metastases, or treatment for cancer or remission from any cancer other than cutaneous basal cell or squamous cell carcinoma resolved by excision for less than 5 years prior to Baseline;
9.History within the previous 6-months 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);
10.Presenting with:
• Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy);
• Any clinically significant active infection;
11.A major surgical operation within 1 month of Baseline;
12.Uncontrolled hypertension or a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg at Baseline;
13.Clinically significant abnormal 12-lead ECG at Baseline;
14.Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments:
• AST or ALT >1.5 x ULN
• Total bilirubin >1.5 x ULN
• Estimated serum creatinine clearance < 30 mL/min
15.Use of any prohibited concomitant medications during the last 2 weeks of the Screening period prior to the start of Baseline
16.Use of any investigational drug agent or device during this study or within 1 month, or 5 half lives, prior to Baseline whichever is longer;
17.History of severe drug induced hypersensitivity (ie, anaphylaxis);
18.Patients with moderate or severe depression or anxiety based on investigator judgment or major depressive/anxiety disorder as defined by DSM-IV diagnostic criteria or depression/anxiety sub-scale score 11 on the Hospital Anxiety and Depression Scale at Baseline;
19.Moderate” or severe” scores on any of the items comprising the Behaviour Monitoring Aid at Baseline;
20.Patients with active suicidal ideation or suicidal behaviour (including suicide attempt) within 2 years prior to Baseline as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or by the investigator’s clinical judgment at the Baseline or Randomization / Day 1 visits;
21.History, diagnosis or signs and symptoms of clinically significant neurological disease, including, but not limited to:
• Alzheimer’s disease or other types of dementia;
22.Inability to comprehend, or unwillingness to follow, the study requirements
23. Patients who do not agree to ab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method