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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002208-24-CZ
• Date of registration: 12/06/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street,New York,NY 10017
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01/08/2008
• Target sample size: 74
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002208-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

POST-HERPETIC NEURALGIA
MedDRA version: 9.1 Level: LLT Classification code 10036376 Term: Post herpetic neuralgia

Intervention(s)

Product Code: CP-526,555
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Varenicline (as tartrate)
CAS Number: 375815-87-5
Current Sponsor code: CP-526,555
Other descriptive name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino(2,3-h)(3)benzazepine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: 1.To evaluate the analgesic efficacy of varenicline versus placebo in patients with postherpetic neuralgia (PHN)

2.To evaluate the safety and tolerability of varenicline versus placebo in patients with postherpetic neuralgia.

3.To characterize the pharmacokinetics of varenicline in patients with post-herpetic neuralgia.

Primary end point(s): The primary endpoint is the change from Baseline period (defined as the period starting on V1 (Day -7) up to and including Day -1 (the day before Day 1/Randomization) to Week 4 in the average weekly pain score using the 11-point NRS (Numeric Rating Scale) daily diary.

Secondary Objective: no further objectives

Secondary ID(s)

A3051103