Postherpetic Neuralgia` MedDRA version: 8.1 Level: LLT Classification code 10029223
Conditions
Interventions
Product Name: [S,S]-Reboxetine Succinate
Product Code: PNU-165442G
Pharmaceutical Form: Tablet
INN or Proposed INN: (+)-[S,S]-Reboxetine succinate
Current Sponsor code: PNU-165442G
Other descriptive
Sponsors
Pfizer AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Male or female, at least 18 years of age · Female patients must be non-pregnant and non-lactating, and be either postmenopausal, surgically sterilized, or using an appropriate method of contraception (including barrier or hormonal method). Women of childbearing potential must have a confirmed negative urine pregnancy test at the Screening visit (Visit 1) · 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 (Visit 1) must have a score =40 mm on the Pain Visual Analogue Scale (VAS) · Patients must be able to understand and cooperate with trial procedures and have signed a written informed consent document 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
Exclusion criteria: · Malignancy within the past 2 years with the exception of basal cell carcinoma · Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN · Creatinine clearance 2 x ULN, Total bilirubin >2 x ULN) · Platelet count 10 on the Hospital and Anxiety Depression Scale · History of recurrent syncope or evidence of low blood pressure (20 mmHg or diastolic blood pressure >10 mmHg on standing (from sitting) · Patients with a history of transient ischemic attacks, stroke, or the presence of a carotid bruit (unless significant carotid stenosis (>70%) has been ruled out by appropriate investigation) · History of uncontrolled narrow angle glaucoma · Patients judged clinically to be a serious suicidal risk · Patients who have a history of a seizure disorder · Previous exposure to either pregabalin or RBX · Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to Visit 1 · Have ever received treatment with vigabatrin, hydroxychloroquine, deferoxamine, thioridazine and or any compound known to adversely affect retina and visual fields · Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of adjunctive treatment of pregabalin with [S,S]-RBX against pregabalin monotherapy in patients with PHN;Secondary Objective: To investigate the safety and tolerability of [S,S]-RBX in adjunctive treatment with pregabalin in patients with PHN;Primary end point(s): Change from baseline to Week 10 in weekly average pain score. Pain intensity is based on the daily pain rating scale of 0-10. | — |
Countries
Czech Republic, Germany, Italy, Latvia, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed