post herpetic neuralgia MedDRA version: 7 Level: LLT Classification code 10036376
Conditions
Interventions
Product Name: pregabalin
Product Code: PD 0144723 (CI-1008)
Pharmaceutical Form: Capsule*
INN or Proposed INN: pregabalin
Current Sponsor code: PD0144723 (CI-1008)
Other descriptive name: (S)-(+)-3-is
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients over 18 years of age Females of child bearing potential must have a negative serum pregnancy test and be practising an acceptable form of contraception (hormonal, barrier or IUD)Diagnosis of PHN with pain present for at least 3 months after healing of Herpes zoster lesions. Pain score of at least 40 mm on the 100 mm visual analogue scale both at screening and randomisation visits. Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average pain rating score of >4 during the 7 days prior to randomisation. Subjects must be in generally good health apart from PHN. Subjects are permitted to continue with other pharmacological or non-pharmacological treatments for pain associated with PHN, but not to change or initiate new treatments Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures. 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: In-patients Women who are pregnant or lactating or not practising an acceptable method of contraception History of neurolytic or neurosurgical therapy Neurological disorders that may confuse or confound the assessment of neuropathic pain. Presence of any severe pain that could confuse or confound the assessment of neuropathic pain. Skin condition in the affected dermatome that could alter sensation Other clinically significant or unstable medical conditions Creatinine clearance 3x ULN Clinically significant abnormal ECG Clinically significant congestive heart failure History of pernicious anaemia or untreated hypothyroidism Malignancy within the past 2 years Active hepatitis B or C, HIV infection or other significant infection in the past 3 months Anticipated need for surgery Total white blood cell count <2500/c. mm or platelet count <100x103/c.mm Drug or alcohol abuse in the past 2 years History of intolerance or hypersensitivity to pregabalin, gabapentin or drugs with similar chemical structures Participation in previous trials with pregabalin Participation in any other study within 30 days of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the time to a 1 point or greater improvement (with accompanying > 30% improvement in weekly pain score at last visit) in the Daily Pain Rating Scale score in subjects with pain associated with PHN, treated with pregabalin 150-600 mg /day flexible dose, pregabalin 300 mg/day fixed dose or placebo;Secondary Objective: Evaluate the safety and tolerability of pregabalin for the treatment of patients with pain associated with PHN. Evaluate the time to an initial decrease of at least 30% in the Daily Pain Rating Scale score . Evaluate the proportion of subjects reporting a decrease of at least 30% in the Daily Pain Rating Scale score by day in each treatment group. Evaluate the proportion of subjects reporting decreases of at least 30% in the mean weekly pain score by the end of double blind treatment in each treatment group. Evaluate the proportion of subjects reporting decreases of at least 50% in the mean weekly pain score by the end of double blind treatment in each treatment group. Evaluate changes in pain intensity Evaluate patient's impression of change Evaluate patient-reported sleep interference Evaluate changes in anxiety (VAS scale) Evaluate changes in brush induced allodynia (VAS scale);Primary end point(s): The time to a 1 point or greater improvement (with accompanying > 30% improvement in weekly pain score at last visit) in the Daily Pain Rating Scale score. | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed